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

Catalog Number 544250

Device Problem Break (1069)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

Qn # (b)(4).Other remarks: n/a.Corrected data: n/a.

Event 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 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".

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
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18182285
• MDR Text Key: 328674321
• Report Number: 3003898360-2023-01557
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704625216
• UDI-Public: 34026704625216
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K133202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1