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

Catalog Number 544965

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2017

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

Issue reported: when the user pulled the trigger to ligate the body tissue, he/she heard an abnormal noise and the jaws of applier got slightly bent.The user tried to pull out the applier from the patient's body but it was difficult because the applier got caught on the port.The patient's condition was reported as fine.

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 (b)(4) as part of a (b)(4).Lot in september of 2016.The returned instrument was evaluated and found that the end of the tube assembly where the jaws are attached is bent and damaged and the pivot pin is popped and the drive rod is also bent where it attaches to the jaws and the jaws are misaligned to each other and loose thus we are able to validate the alleged complaint.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 to be bent/damaged and jaw pivot pin to be popped on one side of the tube and the jaws to be misaligned, but mishandling at the customers facility is suspected.No corrective action required.

Event Description

Issue reported: when the user pulled the trigger to ligate the body tissue, he/she heard an abnormal noise and the jaws of applier got slightly bent.The user tried to pull out the applier from the patient's body but it was difficult because the applier got caught on the port.The patient's condition was reported as fine.

• 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: 6994342
• MDR Text Key: 91202085
• Report Number: 3011137372-2017-00335
• 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: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• 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: 06G1634670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• 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