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

Model Number	IPN915184
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device history review for hemolok l clips 6/cart 84/box lot# 73g2100135 investigation did not show issues related to the complaint.The device investigation is pending and the result will be reported in a follow-up report.
Event or Problem Description
Reported issue: (b)(6)2023, the clip does not close during usage on the patient.Another clip was used.
Event or Problem Description
Reported issue: (b)(6) 2023, the clip does not close during usage on the patient.Another clip was used.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The reported complaint could not be confirmed by the photo.The customer returned two loose clips and one cartridge with four clips remaining of 544240 hemolok l clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.Evidence of use in the form of biological material and slight scrape marks were observed on the returned cartridge.No other defects or anomalies were observed on the returned cartridge.Biological material and scrapes were observed on both loose clips.The loose clips and three clips remaining in the cartridge were loaded into lab inventory appliers and successfully applied to overstressed surgical tubing without breaking on the first attempt.One clip remaining in the cartridge required three attempts to successfully be applied to overstressed surgical tubing.R & d engineering was consulted for this complaint issue.Per r & d, the root cause of the clip failing to latch on its first attempt could not be conclusively determined.A device history record review was performed and no relevant findings were identified.The ifu for this product 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." the reported complaint was confirmed based upon the sample received.R & d engineering was consulted and participated in functional testing for this complaint.According to r & d, the root cause of the clip failing to properly latch on the first attempt could not be conclusively determined.A dhr review was performed with no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16569362
• Report Number: 3003898360-2023-00344
• Device Sequence Number: 20368111
• Product Code: FZP
• UDI-Device Identifier: 24026704695939
• UDI-Public: 24026704695939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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: 07/04/2026
• Device Model Number: IPN915184
• Device Catalogue Number: 544240
• Device Lot Number: 73G2100135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 03/18/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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: Unknown