MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number UNKNOWN LIGASURE INSTRUMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

Title: comparison of uterine scarring between robot-assisted laparoscopic myomectomy and conventional laparoscopic myomectomy source: journal of obstetrics and gynaecology, 40:7, 974-980, published online: 02 dec 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, 203 patients underwent myomectomy by two specialists between january 2014 and april 2017.110 women underwent laparoscopic myomectomy, and 93 women underwent robot-assisted laparoscopic myomectomy.In all procedures, the ligasure was used to make a line into the myometrium and deepened until the myoma surface appeared.After the myoma was removed, the ligasure was used to separate the capsule from the myoma.The myometrial wound was repaired using v-loc.Seven days post-operatively, six patients developed a hematoma, one of which also had a pelvic infection that needed ct-guided drainage of the hematoma and antibiotic treatment.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10740905
• MDR Text Key: 213215294
• Report Number: 1717344-2020-01296
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LIGASURE INSTRUMENT
• Device Catalogue Number: UNKNOWN LIGASURE INSTRUMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR