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

Catalog Number 544965

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the screw of the jaw was found protruding during usage on patient.

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 wi facility as part of a 50 pc.Lot in (b)(6) 2019.Evaluation of the returned device shows that one of the jaws is missing and the jaw pivot pin has been pushed thru one side of the outer tube assembly and is loose along with the other jaw thus making this device unusable in the field.We are unable to determine what caused the jaws to be damaged and missing on this device but mishandling 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 customer as this is a standardized procedure for this product line at this facility.

Event Description

It was reported that the screw of the jaw was found protruding during usage on patient.

• Brand Name: HOL ML 5 MILLIMETER ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 9140230
• MDR Text Key: 166763991
• Report Number: 3011137372-2019-00321
• 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,u
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• 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: 06B1865269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.