MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Model Number IPN915182

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok ml clips 6/cart 84/box lot# 73d2000174 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

A clip fell from the applier after it was loaded during a laparoscopic cholecystectomy.It occurred several times.Therefore, the user opened a new cartridge instead, with which no loading failure occurred.

Manufacturer Narrative

Qn#: (b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.Two loose clips were also returned, one closed and one opened.The clip cartridge was visually examined with and without magnification.Visual examination of the returned cartridge revealed that there were 3 clips remaining in the cartridge.The sample appears used as there was biological material present on the device.Functional inspection was performed on the returned sample.A lab inventory clip applier was used.All three remaining clips from the cartridge were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing.The loose clip that was opened was manually loaded into the jaws of the applier and was also successfully applied to over-stressed surgical tubing.No functional issues were found with the returned clips.It is possible that the reported issue of "loaded clip is insecurely seated" was caused by using damaged/misaligned appliers, but this could not be confirmed since the applier was not returned.The ifu for this product, l06110, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." a corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of "loaded clip is insecurely seated" was not confirmed based upon the sample received.Upon functional inspection, all remaining clips were able to properly load into the jaws of a lab inventory applier and were successfully applied to over-stressed surgical tubing.No damages were observed to any of the returned clips.It is possible that the reported loading issue was caused by using damaged/misaligned appliers, but this could not be confirmed since the applier was not returned.Since no functional issues were found with the returned clips and the applier was not returned, the reported issue could not be confirmed.

Event Description

A clip fell from the applier after it was loaded during a laparoscopic cholecystectomy.It occurred several times.Therefore, the user opened a new cartridge instead, with which no loading failure occurred.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12728102
• MDR Text Key: 279285773
• Report Number: 3003898360-2021-01033
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 24026704695915
• UDI-Public: 24026704695915
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915182
• Device Catalogue Number: 544230
• Device Lot Number: 73D2000174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.