MAUDE Adverse Event Report: TELEFLEX MEDICAL VLOCK LG CLIP 6/CART 14/BOX; CLIP, IMPLANTABLE

Model Number	IPN921001
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device investigation is pending and the results will be submitted in a follow-up report.
Event or Problem Description
Reported issue: urologist was using the vesolock in a robotic prostatectomy and clips would not lock.Three packs of cartridges ope ned and attempted but there was the same problem with all packs.Hem-o-loc found and used successfully as a result.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one cartridge with packaging, two intact clips, and two loose clips of 61114v vlock lg clip 6/cart 14/box for investigation.No clip applier was returned.The returned sample was visually examined with and without magnification.Biological material was observed on the clips and cartridge.An unacceptable level of flash/hook deformation was observed on the first returned intact clip.This defect was not present on the other returned clips.Dimensional inspection was not required as a part of this complaint investigation.A functional inspection was performed on the returned clips.The flash/hook deformation was likely responsible for this failure.An nc was opened to further investigate this issue.The remaining clips were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing.The finished goods device history was reviewed and lot number 228053 of product 61114v vlock lg clip 6/cart 14/box investigation did not show issues related to the complaint.The ifu for this product, 15-lb-00368 rev.00, was reviewed as a part of this complaint investigation.The ifu states, "manual-load applier/remover jaws are delicate and can easily become damaged, as can some other applier/remover components.Mishandling of applier/removers may result in improper load and/or closure of the jaws.Appropriate care, cleaning, lubrication and maintenance are important to ensure proper function.Please examine the applier/remover before each surgery for potential damage." an unacceptable level of flash/hook deformation was observed on the first returned intact clip.An nc was opened to further investigate this issue.The reported complaint of clips not closing/locking was confirmed with the returned sample.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Reported issue: urologist was using the vesolock in a robotic prostatectomy and clips would not lock.Three packs of cartridges ope ned and attempted but there was the same problem with all packs.Hem-o-loc found and used successfully as a result.

• Brand Name: VLOCK LG CLIP 6/CART 14/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15933958
• Report Number: 3011137372-2022-00233
• Device Sequence Number: 17260131
• Product Code: FZP
• UDI-Device Identifier: 14026704737441
• UDI-Public: 14026704737441
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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 Expiration Date: 03/01/2025
• Device Model Number: IPN921001
• Device Catalogue Number: 61114V
• Device Lot Number: 228053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Male