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

Catalog Number 544965

Device Problems Bent (1059); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2017

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 clip bent during use.No patient injury or medical intervention was reported for this event.The patient is reported to be fine.Additional information indicates that the clip applier was used successfully during the initial use.On the second application the instrument got bent and the clip application failed.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found complete 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 as received the tube assembly where the jaws are attached is bent/damaged and the jaws are gouged, loose and misaligned and the jaw pivot pin is slightly popped and sticking out on one side of the tube assembly.Results/root cause/conclusions: parts were 100% visually inspected and tested at the (b)(4) 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.At this time it is un-determined what caused the tube assembly where the jaws are attached to be bent/damaged and the jaws to be gouged, loose and misaligned and the jaw pivot pin to be slightly popped and sticking out on one side of the tube assembly but mishandling at the customers facility is suspected.

Event Description

It was reported that the clip bent during use.No patient injury or medical intervention was reported for this event.The patient is reported to be fine.Additional information indicates that the clip applier was used successfully during the initial use.On the second application the instrument got bent and the clip application failed.

• 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: 6997553
• MDR Text Key: 91375167
• Report Number: 3011137372-2017-00352
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• 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: 06M1526937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• 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