MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCL0306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); Unintended Radiation Exposure (4565)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: comparison of uterine scarring between robot-assisted laparoscopic myomectomy and conventional laparoscopic myomectomy source: journal of obstetrics and gynaecology 2020, volume 40, no.7, pages 974-980.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source of study, 203 patients underwent myomectomy by two specialists between 2014 and 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: V-LOC 180
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 10733305
• Report Number: 1219930-2020-04439
• Device Sequence Number: 1872183
• Product Code: GAM
• UDI-Device Identifier: 10884521130944
• UDI-Public: 10884521130944
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K091087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: VLOCL0306
• Device Catalogue Number: VLOCL0306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR