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

Model Number	IPN915181
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device history review for the product hemolok med clips 6/cart 84/box lot# 73d2000191 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 or Problem Description
A clip got broken at loading.Therefore, a new cartridge was opened to complete the procedure.
Event or Problem Description
A clip got broken at loading.Therefore, a new cartridge was opened to complete the procedure.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one cartridge (b)(4) hemolok med clips 6/cart 42/box for investigation.The cartridge was returned with half of a clip remaining.The clip half was the pierced boss half.One clip half was returned loose , and this clip half was the hook half.Another clip was returned loose , and this clip had its pierced bosses broken off.The broken pierced bosses were inside the cartridge.The cartridge and clips were visually examined further with and without magnification.Visual examination revealed that the sample appeared used as there was biological material on both clips.The two clip halves were not broken at the hinge, they were broken on the pierced boss leg right before the double hinge.R & d engineering was consulted for this complaint issue.According to r & d, it could not be determined what exactly caused the defects seen.It is possible that the defects were caused by the clips being produced on cavities pre-maintenance.Project (b)(4) was completed in 2021 to resolve this issue.These clips were manufactured prior to the project completion.It is also possible that the observed damage to the broken clips is from improper loading of the clips or by using damaged appliers.This could not be confirmed since the appliers were not returned for investigation.The ifu for this product, l02425, 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." "do not force the applier into the cartridge or onto the clip.The applier should enter and withdraw from the cartridge easily.Remove the applier from the cartridge ensuring the clip is held securely in the applier jaws.It may be necessary to hold the cartridge to allow the clip to be removed." although the root cause could not be determined, it is possible that the defect was caused by the clips being produced on cavities pre-maintenance.According to r & d, project (b)(4) was completed in 2021 to resolve this issue.These clips were manufactured prior to the project completion.The reported complaint of "broken clip - multiple locations" was confirmed based on the sample received.The cartridge was returned with two damaged clips.One clip was broken on the pierced boss leg near the hinge.The other clip had its pierced bosses broken off.R & d was consulted for this complaint issue and it could not be determined what exactly caused the defects seen.It is possible that the defects were caused by the clips being produced on cavities pre-maintenance.A project was completed in 2021 to resolve this issue.These clips were manufactured prior to the project completion.It is also possible that the observed damage to the broken clips is from improper loading of the clips or by using damaged appliers.This could not be confirmed since the appliers were not returned for investigation.Therefore, the root cause for this complaint issue is undetermined.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HEMOLOK MED CLIPS 6/CART 84/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12158989
• Report Number: 3003898360-2021-00632
• Device Sequence Number: 4700796
• Product Code: FZP
• UDI-Device Identifier: 24026704695908
• UDI-Public: 24026704695908
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 04/06/2025
• Device Model Number: IPN915181
• Device Catalogue Number: 544220
• Device Lot Number: 73D2000191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.