MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS 3/CART 42/BOX; CLIP, IMPLANTABLE

Catalog Number 544243

Device Problem Component Missing (2306)

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

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok l clips 3/cart 42/box lot# 73d2200853 investigation did not show issues related to the complaint.

Event Description

On (b)(6) 2022, hook was found missing prior to the patient.Additional information indicates that the clips were being prepared for a surgical procedure but were not used on the patient.

Manufacturer Narrative

(b)(4).The customer provided three photos for analysis.The complaint of "broken/detached parts - clip - boss" was able to be confirmed by the photos.The customer returned one cartridge with one broken clip from one unit of 544243 hemolok l clips 3/cart 42/box for investigation.The returned components were visually examined with and without magnification.Visual examination revealed that the cartridge retainer was bent, and that the broken clip had broken pierced bosses.The clip appears used, as there is biological material present on it.The ifu for this product 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." in summary, the reported complaint of "broken/detached parts - clip - boss" was confirmed based upon the sample received.One cartridge with one broken clip was returned.The cartridge had a bent retainer, and the broken clip had broken pierced bosses.R & d was consulted for this complaint, and it was determined that the observed damage to the broken clip is consistent with excessive force during loading of the clip.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

(b)(6) 2022,hook was found missing prior to the patient.Additional information indicates that the clips were being prepared for a surgical procedure but were not used on the patient.

• Brand Name: HEMOLOK L CLIPS 3/CART 42/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: 15328755
• MDR Text Key: 301093558
• Report Number: 3003898360-2022-00433
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544243
• Device Lot Number: 73D2200853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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