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

Model Number	IPN055290
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported event: reports from the operating room that the clips come unlocked during testing.No patient has been involved.
Event or Problem Description
Reported event: reports from the or that the clips come unlocked during testing.No patient has been involved.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
(b)(4).The customer returned one cartridge of 51114v vlock ml clip 6/cart 14/box for investigation.No clip applier was returned.The cartridge was visually examined with and without magnification.Four intact clips , one broken clip, and one broken hook half were remaining in the cartridge.No defects or anomalies were observed on the returned cartridges.Functional inspection was performed on the returned clips.A lab inventory clip applier was used.All clips were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing without detaching.R & d was consulted regarding this issue.Per r & d, the root cause for the two broken clips could not be determined as this is the first confirmed complaint for this issue.The supplier (robling medical) was also consulted regarding this issue.Per robling medical, the clip vendors reviewed materials used, equipment/tooling, production practices, and inspection data.No applicable findings could be identified.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 one cartridge with 4 intact clips, one broken clip, and one broken hook half.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 without breaking.A dhr review was performed with no evidence to suggest a manufacturing related issue.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.Since all clips latched without breaking, the complaint cannot be confirmed.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
Reported event: reports from the or that the clips come unlocked during testing.No patient has been involved.

• 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 ; 9194332672
• MDR Report Key: 16421682
• Report Number: 3011137372-2023-00042
• Device Sequence Number: 5341426
• Product Code: FZP
• UDI-Device Identifier: 24026704666823
• UDI-Public: 24026704666823
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2023

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 Expiration Date: 03/01/2025
• Device Model Number: IPN055290
• Device Catalogue Number: 51114V
• Device Lot Number: 228044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 03/17/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/21/2023; 01/02/2024
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown