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

Model Number	IPN921000
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient during a non-robotic laparoscopic cholecystectomy, the clips did not close properly.As a result, new clips were used to successfully complete the procedure.No patient harm or injury.The patient status is reported as fine.
Event or Problem Description
It was reported that while in use on a patient during a non-robotic laparoscopic cholecystectomy, the clips did not close properly.As a result, new clips were used to successfully complete the procedure.No patient harm or injury.The patient status is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned 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 and slight scrape marks were observed on the clips.No other defects or anomalies were observed.Functional inspection was performed on the returned clips.A lab inventory clip applier was used.Both clips were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing without detaching.It is possible that the reported issue was caused by using damaged/misaligned appliers, but this could not be confirmed since the appliers were not returned for investigation.No functional issues were found with the returned clips.A device history record review was performed and no relevant findings were identified.The instructions for use informs the user, "to load the applier, grasp the applier and carefully insert the jaws of the applier into the cartridge slot, making sure the jaws are perpendicular to the base of the cartridge.Gently press the applier over the clip until there is an audible click.Do not force the applier into the cartridge or onto the clip.The applier should enter and withdraw from the cartridge easily." the reported complaint could not be confirmed.The customer returned two loose clips.Upon functional inspection, the clips could be loaded into the jaws of a lab inventory applier and were able to properly close onto over-stressed surgical tubing with no issues.A dhr review was performed with no evidence to suggest a manufacturing related issue.Since there were no functional issues with the returned clips, the complaint cannot be confirmed.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: VLOCK ML 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17020380
• Report Number: 3011137372-2023-00148
• Device Sequence Number: 7378547
• Product Code: FZP
• UDI-Device Identifier: 14026704737434
• UDI-Public: 14026704737434
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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: IPN921000
• Device Catalogue Number: 51114V
• Device Lot Number: 228147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown