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

Catalog Number 544995

Device Problems Failure to Align (2522); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2017

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

Issue reported: the jaws are not able to hold the clips, might be because of misalignment issue.There was no patient injury.

Manufacturer Narrative

Qn#: (b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) facility as part of a (b)(4) pc.Lot in january of 2015.The returned instrument was evaluated and found that the knob and tube assembly move freely back and forth when the handle is squeezed indicating the snap ring which holds the knob & tube assembly to the handle has been popped out of its groove thus validating the complaint.Parts were 100% visually inspected and tested at the (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.We are unable to determine how this instrument has been stored, handled and cleaned by the end users facility.At this time it is undetermined as to what caused the snap ring to pop and the shaft and knob assembly to become loose from the handle but mishandling at the customers site is suspected.Product failure was caused by failure of a single component, and is an isolated event.Manufacturing other remarks: process of product, or design are not suspected to be at fault.

Event Description

Issue reported: the jaws are not able to hold the clips, might be because of misalignment issue.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: 7044564
• MDR Text Key: 93084185
• Report Number: 3011137372-2017-00368
• 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: 05/05/2017

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: 06A1496937
• 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