TY - JOUR
T1 - Hysteroscopic morcellation
T2 - Review of the manufacturer and user facility device experience (MAUDE) database
AU - Haber, Karina
AU - Hawkins, Eleanor
AU - Levie, Mark
AU - Chudnoff, Scott
N1 - Publisher Copyright:
© 2015 AAGL.
PY - 2015/1/1
Y1 - 2015/1/1
N2 - Study Objective: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. Design: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). Setting: N/A. Patients: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. Interventions: The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. Measurements and Main Results: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n=14), bowel damage (n=12), hysterectomy (n=6), and death (n=2). Minor events included uterine perforation requiring no other treatment (n=29), device failure (n=25), uncomplicated fluid overload (n=19), postoperative bleeding controlled using noninvasive measures (n=6), and pelvic infection (n=4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. Conclusions: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.
AB - Study Objective: To investigate the number and type of adverse events associated with hysteroscopic morcellation of intrauterine disease. Design: Systematic review of Manufacturer and User Device Experience (MAUDE) database from 2005 to June 2014 (Canadian Task Force classification III). Setting: N/A. Patients: Women undergoing hysteroscopic surgery for removal of intrauterine polyps or myomas with use of a reciprocating morcellator. Interventions: The MAUDE database was searched for the key words "Hysteroscope," "Hysteroscopic reciprocating morcellator," "Interlace," "MyoSure," "Smith & Nephew," and "TRUCLEAR," to identify reported incidences of device malfunction, injury, or death. A total of 119 adverse events were analyzed. Reports were reviewed individually and categorized by date of occurrence, type of morcellation device, type of complication, and a brief description. Each company was contacted to provide an estimate of the number of procedures performed or units sold to date. Measurements and Main Results: From 2005 to June 2014, 119 adverse events were reported to the MAUDE database. On the basis of severity, adverse events were categorized as major or minor complications. Major events included intubation/admission to an intensive care unit (n=14), bowel damage (n=12), hysterectomy (n=6), and death (n=2). Minor events included uterine perforation requiring no other treatment (n=29), device failure (n=25), uncomplicated fluid overload (n=19), postoperative bleeding controlled using noninvasive measures (n=6), and pelvic infection (n=4). These events were then categorized according to manufacturer. The number of adverse events reported to the MAUDE database was divided by the total units sold as a surrogate for the estimated number of procedures performed. Understanding the limitation of the numbers used as a numerator and denominator, we concluded that adverse events complicated hysteroscopic morcellation in <0.1% cases. Conclusions: The suction-based, mechanical energy, rotating tubular cutting system was developed to overcome adverse events that occur during traditional resectoscopy. On the basis of acknowledged limited information from the MAUDE database, it seems that life-threatening complications such as fluid overload, uterine perforation, and bleeding do occur with hysteroscopic morcellation but less frequently than with traditional electrocautery.
KW - Hysteroscope
KW - Hysteroscopic reciprocating morcellator
KW - Interlace
KW - MyoSure
KW - Smith & Nephew
KW - TRUCLEAR
UR - http://www.scopus.com/inward/record.url?scp=84920552353&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84920552353&partnerID=8YFLogxK
U2 - 10.1016/j.jmig.2014.08.008
DO - 10.1016/j.jmig.2014.08.008
M3 - Article
C2 - 25128851
AN - SCOPUS:84920552353
SN - 1553-4650
VL - 22
SP - 110
EP - 114
JO - Journal of Minimally Invasive Gynecology
JF - Journal of Minimally Invasive Gynecology
IS - 1
ER -