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

Catalog Number 544965

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

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 jaw of the applier was bent easily and the screw was detached during use.There was no patient injury.

Manufacturer Narrative

(b)(4).The dhr for the alleged instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) as part of a 50pc.Lot in (b)(6) of 2016.The returned instrument was evaluated and found that the knob rotation was extremely sluggish/dry and the tube assembly is damaged/bent open at the jaw end and the jaws are loose and misaligned and the drive rod is bent/damaged at the jaw end and the pivot pin has been slightly pulled thru 1 side of the tube assembly but no parts are missing from instrument.We are able to validate this complaint.Parts were 100% visually inspected and tested at the (b)(4) before instruments were sent to customer.No irr egularities 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.At this time it is un-determined what caused the knob rotation mechanism to be sluggish and the tube assembly to be damaged and for the drive rod to be bent at the jaw engagement area and for the jaws to be loose and misaligned and the jaw pivot pin to be pulled into the outer tube assembly but mishandling and lack of proper lubrication at end users facility is suspected.

Event Description

It was reported that the jaw of the applier was bent easily and the screw was detached during use.There was no patient injury.

• Brand Name: HOL ML 5 MILLIMETER ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7637951
• MDR Text Key: 112345085
• Report Number: 3011137372-2018-00166
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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: 06B1629321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1