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

Catalog Number 544965

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 during 2nd clip ligation, the part which holds jaws got loose and the applier was replaced by a new one.There was no patient injury.

Manufacturer Narrative

(b)(4).Evaluation of the returned instrument shows that the tube assy.Is damaged at the jaw end and the jaw pivot pin is popped and the jaws are loose and misaligned to each other.Further evaluation shows deep scratches and gouging in the jaws and around pivot pin hole.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.At this time it is un-determined what caused the tube assembly to be bent open/damaged and the jaws to be scratched/gouged and loose and the jaw pivot pin to be slightly popped out of the tube assembly, but mishandling at the customers facility is suspected.Corrective action: no corrective action required at this time.

Event Description

It was reported that during 2nd clip ligation, the part which holds jaws got loose and the applier was replaced by a new one.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 tecomet, kenosha facility as part of a 50pc.Lot in march of 2017.This instrument was not returned, but submitted pictures show that the jaws are slightly loose and the end of the tube assy.Looks slightly bent open and the pivot pin is slightly popped on one side of the tube.Parts were 100% visually inspected and tested at the (b)(4) facility 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 jaws to be slightly loose and the jaw pivot pin to be slightly popped out of the tube assembly, but mishandling at the customers facility is suspected.

Event Description

It was reported that during 2nd clip ligation, the part which holds jaws got loose and the applier was replaced by a new one.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: 7129533
• MDR Text Key: 95469239
• Report Number: 3011137372-2017-00397
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• 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: 06H1638576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• 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