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

Model Number	VLOCM0013
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/04/2021
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, during a procedure, upon closing the pace-maker pocket after inserting a pace maker, needle was separated from the thread.When the tissue was closed with suture, the needle came loose from the thread and was dropped into the wound.The needle and suture split up or the needle release from the suture and went off.There was trouble in finding the needle as it fell down into the tissue of patient, but it was removed from the wound cavity and scrapped according to their routine.It prolonged the operation with 30 minutes and an x-ray was performed in locating the needle.A new suture from the same package and continued the suturing of the tissue without any incident.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 11392006
• Report Number: 1219930-2021-00804
• Device Sequence Number: 3286592
• Product Code: GAM
• UDI-Device Identifier: 10884521131644
• UDI-Public: 10884521131644
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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 Expiration Date: 05/31/2023
• Device Model Number: VLOCM0013
• Device Catalogue Number: VLOCM0013
• Device Lot Number: A0F0390VFY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/01/2021
• 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