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

Model Number IPN915189

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/15/2023

Event Type  malfunction  

Event Description

As a result, it was replaced with a new unit to complete the procedure.Nothing fell/remained in the patient and no injury to the patient occurred.The patient status is reported as "fine".

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The sample was returned and sent to the manufacturing site (tecomet) for investigation.Tecomet reports "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 (b)(4) pc.Lot in october of 2021.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 bent towards the left in the bent/damaged outer tube assembly and are loose and misaligned to each other in the closed position.Further evaluation shows that the jaw pivot pin is pulled thru one side of the outer tube assembly.We are able to validate the 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 the bosses are both damaged where they engage the jaws.We are unable to determine what caused the drive rod to be bent and for the bosses to become damaged and for the jaws and outer tube assembly to be bent/damaged and for the jaw pivot pin to be pulled thru one side of the outer tube assembly but mishandling of this device at the end user's facility is suspected.All (b)(4)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." other remarks: n/a.Corrected data: n/a.

Event Description

As a result, it was replaced with a new unit to complete the procedure.Nothing fell/remained in the patient and no injury to the patient occurred.The patient status is reported as "fine.".

• 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; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16941151
• MDR Text Key: 315322397
• Report Number: 3011137372-2023-00149
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704696813
• UDI-Public: 24026704696813
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915189
• Device Catalogue Number: 544965
• Device Lot Number: 06K2005168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: N/A.; N/A.