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

Model Number	VLOCL2836
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While suturing vaginal cuff after laparoscopic vaginal assisted hysterectomy, with 2-0 v-loc suture, the needle broke in two parts, surgeon was able to retrieve one part of the suture needle.They looked for the other needle portion, but it was not found within patient.Retained needle portion seen in abdomen on x-ray.Decision was made retain needle segment as felt there was no way to safely remove it.Vendor informed.Manufacturer response for suture, absorbable, synthetic, polyglycolic acid, v-loc 180 (per site reporter).

• Brand Name: V-LOC 180
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 24188558
• Report Number: 24188558
• Device Sequence Number: 18116311
• Product Code: GAM
• UDI-Device Identifier: 10884521214729
• UDI-Public: (01)10884521214729
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/12/2026
• Report Date (Section F): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VLOCL2836
• Device Lot Number: N5F1579Y
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 01/12/2026