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

Model Number	VLOCL3216
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); No Code Available (3191)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, following a total laparoscopic hysterectomy, patients developed postoperative infection/ cellulitis on their vaginal cuff.Due to benign diseases, eighty-nine patients were in the standard suture group and 208 patients were included in the barbed suture group.Vaginal cuff dehiscence was identified in only three (3.3%) patients within the standard suture group and none in the barbed suture group.Five (5.6%) patients in the standard suture group and two (0.9%) patients in the barbed suture group developed postoperative cuff infection/cellulitis.Duration of the surgery was significantly shorter in the barbed suture group than in the standard suture group.180 unidirectional barbed suture, which was used during surgery for vaginal cuff closure, is an applicable, safe and tolerable alternative to a standard suture.At present, there were only a limited number of studies of regarding the suture in the literature.What the results of this study demonstrated that barbed sutures used for enabling vaginal cuff integrity did not cause major morbidity and mortality for the patient.They suggested that the barbed sutures offer a practical, safe and tolerable alternative for surgeons because they were easy to use, do not cause a significant increase in vaginal cuff complications, and shorten the operating time.They believed that the barbed suture, the surgery results of which were openly discussed in the study, will be more prominent in clinical practice owing to the shortened operating time, and that the use of these sutures did not cause a significant increase in vaginal cuff complications.Patients who had complications were treated using antibiotherapy under out-patient conditions.

• 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: 7472248
• Report Number: 1219930-2018-02342
• Device Sequence Number: 157715
• Product Code: GAM
• UDI-Device Identifier: 10884521215139
• UDI-Public: 10884521215139
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K091087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature,user facil
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: VLOCL3216
• Device Catalogue Number: VLOCL3216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 04/30/2018
• 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