MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L 10MM ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544995

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2017

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 applier clips get stuck in the jaw while performing surgery.The clip gets stuck in the jaw and does not come out.There was no patient injury.

Manufacturer Narrative

Qn# (b)(4).The dhr for the alleged instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the teleflex medical, kenosha facility as part of a 50 pc.Lot in october of 2015.We are unable to validate the alleged complaint at this time.The returned instrument was evaluated and found that the jaws are aligned both in the open and closed position and the open jaw gap was measured at (.379) which is within print specifications of (.385 +/-.025)and the closed jaw gap was measured at (.008) which is in print specifications of (.004/.012).Further evaluation of the jaws did not show any signs of damage to either jaw and that this instrument is able to pick-up, retain, close and release multiple clips both with and without the use of silastic tubing.We are unable to replicate the alleged issue therefore we are unable to validate this complaint.Parts were 100% visually inspected and tested at the tecomet, inc.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.No further action required at this time.

Event Description

It was reported that the applier clips get stuck in the jaw while performing surgery.The clip gets stuck in the jaw and does not come out.There was no patient injury.

• Brand Name: HOL L 10MM 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: 7044603
• MDR Text Key: 93060026
• Report Number: 3011137372-2017-00369
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544995
• Device Lot Number: 06C1516004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• 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