MAUDE Adverse Event Report: Covidien Surgical V-Loc 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	VLOCM0114
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction

• Brand Name: V-Loc 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): Covidien Surgical; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): Covidien Surgical; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50860051
• Report Number: 1219930-2026-05874
• Device Sequence Number: 13150055
• Product Code: GAM
• UDI-Device Identifier: 10884521131750
• UDI-Public: (01)10884521131750(17)270930(10)A4K1799VFY(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: VLOCM0114
• Device Catalogue Number: VLOCM0114
• Device Lot Number: A4K1799VFY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 10/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown