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

Catalog Number	544250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn # (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "during open splenectomy surgery, the clip broke after it was locked".The broken clip was removed from the patient and no parts/fragments were left in the patient.No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that "during open splenectomy surgery, the clip broke after it was locked".The broken clip was removed from the patient and no parts/fragments were left in the patient.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The complaint of "broken parts - clip - leg" was confirmed based upon the sample received.Visual examination revealed that the returned clip was broken at the hook leg.Gouge marks were observed on the returned clip.Per r & d, the observed damage is consistent with the use of improper technique or misaligned appliers during loading.A dhr review was performed with no evidence to suggest a manufacturing related cause.Therefore, based upon the returned sample, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HEMOLOK XL 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18182285
• Report Number: 3003898360-2023-01557
• Device Sequence Number: 7793408
• Product Code: FZP
• UDI-Device Identifier: 34026704625216
• UDI-Public: 34026704625216
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K133202
• 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): 11/15/2023

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 Catalogue Number: 544250
• Device Lot Number: 73J2200508
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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
• Patient Sex: Unknown