MAUDE Adverse Event Report: COVIDIEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCM2245
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During a case it was noted that temporary v-locs kept braking.Staff went through 3 of them then decided to use a different lot number.The physician stated he did not put any strain that it had any reason to brake.A fourth device of a different lot was successfully used with no harm to the patient.Unfortunately the defective vlocs were not saved, nor was a lot number recorded.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 8603332
• Report Number: 8603332
• Device Sequence Number: 1857526
• Product Code: GAM
• UDI-Device Identifier: 10884521133037
• UDI-Public: (01)10884521133037
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2019
• Report Date (Section F): 04/22/2019

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: VLOCM2245
• Device Catalogue Number: VLOCM2245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68
• Date Report Sent to FDA: 04/22/2019