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

Catalog Number 544965

Device Problem Misfire (2532)

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

Event Date 08/17/2021

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

The jaws of the applier was found misaligned during a pretest before use.Therefore, a new unit was used instead.The applier was purchased by the hospital on (b)(6) 2021.

Event Description

The jaws of the applier was found misaligned during a pretest before use.Therefore, a new unit was used instead.The applier was purchased by the hospital on june 1 2021.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc.Kenosha, wi facility as part of a 50-piece lot in june of 2020.Evaluation of the returned instrument shows that the tips are slightly loose and misaligned in the closed position therefore we are able to validate this complaint.Functional evaluation shows that although the tips are slightly loose and misaligned in the closed position this instrument is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing.We are unable to determine what caused the tips to be slightly loose and misaligned in the closed position 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
• MDR Report Key: 12371593
• MDR Text Key: 268275865
• Report Number: 3011137372-2021-00219
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: 06B2098690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1