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

Catalog Number 544995

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (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 two weck 10mm hem-o-loks have failed during cases.In both cases once the clip was locked; could not open.

Manufacturer Narrative

Qn#(b)(4).The dhr for the returned device was reviewed and found completely without any irregularities.This instrument was produced at the tecomet inc.Kenosha facility as part of a (b)(4) pc.Lot in (b)(6)2018.Evaluation of the returned device showed that the handle mechanism was binding and that when it is actuated the jaws do not move therefore , we are able to validate this complaint.Further evaluation after the tube assembly was removed from the knob assembly shows that the end of the drive rod that actuates the jaws when the handle is actuated is broken off.All (b)(4) instruments from this lot were 100% visually inspected and function tested prior to shipment to customer.We are unable to determine what caused the drive rod end to be broken at the jaw end but mishandling at the end user's facility is suspected.

Event Description

It was reported that two weck 10mm hem-o-loks have failed during cases.In both cases once the clip was locked; could not open.

• Brand Name: HOL L 10MM ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8574018
• MDR Text Key: 143845581
• Report Number: 3011137372-2019-00148
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544995
• Device Lot Number: 06A1863153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1