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

Catalog Number 544965

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2017

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 applier did not release some clips during ligation.Another applier was used.There was no patient injury.

Manufacturer Narrative

(b)(4).The dhr for the instruments in question was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, kenosha facility as part of a 50pc.Lot in (b)(6) 2015.The returned instrument was evaluated and found that the jaws are in line with each other in the open and closed position and there are no visible signs to the jaws.Further evaluation showed that this instrument picks up, retains, closes and releases multiple clips as required of its function both with and without the use of silastic test tubing.Parts were 100% visually inspected and tested at the tecomet, kenosha 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.We are unable to validate the alleged complaint since we were unable to replicate the alleged issue.At this time it is un-determined what caused the alleged issue at the customers site.No corrective action required at this time.Per fda guidelines for manufacturers which state: "manufacturers are other remarks: required to report to the fda when they learn that any of their devices may have caused or contributed to a death or serious injury.

Event Description

It was reported that the applier did not release some clips during ligation.Another applier was used.There was no patient injury.

• Brand Name: HOL ML 5MM 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: 6568893
• MDR Text Key: 75234345
• Report Number: 3011137372-2017-00170
• 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
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06G1521033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• 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