MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544965

Device Problem Material Twisted/Bent (2981)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the jaws of the applier got bent during use.Therefore, the applier was replaced with a new one to complete the procedure.Nothing fell/remained in the patient and no patient injury occurred".The status of the patient is reported as "fine".

Event Description

It was reported that "the jaws of the applier got bent during use.Therefore, the applier was replaced with a new one to complete the procedure.Nothing fell/remained in the patient and no patient injury occurred".The status of the patient is reported as "fine".

Manufacturer Narrative

(b)(4).The complaint sample was returned.Tecomet, the manufacturing site reported: "the dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a 50-pc.Lot in february of 2023.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned instrument shows that the jaws are loose and misaligned to each other and bent to the left and the jaw pivot pin is pulled thru one side of the damaged/bent outer tube assembly.(pie's attached) we are able to validate this complaint for the returned instrument.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod (n00185) is bent, and its bosses are both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused all the damage to the components on this device but mishandling such as excessive force being applied to the handle to jaw mechanism on this device at the end user's facility is suspected.All 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HOL ML 5MM ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 17977185
• MDR Text Key: 326172354
• Report Number: 3003898360-2023-01438
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 34026704623625
• UDI-Public: 34026704623625
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06F2250323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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