MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L ENDO APPLIER 10MM 45CM; APPLIER, SURGICAL, CLIP

Catalog Number 544995L

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device is not operating correctly.Jaws of applier will close but not open rapidly or at all, which prevents introduction of next hem-o-lok clip.There was no patient injury.

Event Description

It was reported that the device is not operating correctly.Jaws of applier will close but not open rapidly or at all, which prevents introduction of next hem-o-lok clip.There was no patient injury.

Manufacturer Narrative

(b)(4).The dhr for the instrument in question was reviewed and found completely without any irregularities.This instrument was manufactured as a 544995l at the tecomet, inc.(b)(4) facility as part of a 25 pc.Lot in july of 2017.The returned instrument was evaluated and found that as received the handle to jaw mechanism were binding making it difficult to pick-up, retain, close and release a clip thus we are able to validate the alleged complaint.Further evaluation revealed that once disassembled the bottom end of the drive rod (n00190l) where the finger pins engage with the jaws was badly bent, twisted and damaged.We are able to validate this complaint.Parts were 100% visually inspected and tested at the tecomet, inc.(b)(4) facility before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.We are unable to determine how this instrument has been stored, handled and cleaned by the end users facility.At this time it is undetermined as to how this was caused but over squeezing of handle to jaw mechanism /mishandling at the end users facility is suspected.

• Brand Name: HOL L ENDO APPLIER 10MM 45CM
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7210177
• MDR Text Key: 98181640
• Report Number: 3011137372-2018-00019
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544995L
• Device Lot Number: 06C1748177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Date Manufacturer Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1