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 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the jaws of the applier got bent during a surgery.Therefore, it was replaced with a new unit to complete the procedure.The patient's condition was reported as fine.

Event Description

It was reported that the jaws of the applier got bent during a surgery.Therefore, it was replaced with a new unit to complete the procedure.The patient's condition was reported as fine.

Manufacturer Narrative

Qn# (b)(4).The device history 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 july 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 to the left, loose, and misaligned to each other.The pivot jaw pin is pulled through one side of the bent/damaged outer tube assembly.We are able to validate this complaint.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 is bent/damaged, 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 the drive rod to become bent and for its bosses to become damaged and the jaw piv ot pin to be pulled through one side of the bent/damaged outer tube assembly but mishandling of 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.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15987363
• MDR Text Key: 308069192
• Report Number: 3011137372-2022-00241
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 14026704696816
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• 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: 06E2002050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED