MAUDE Adverse Event Report: TELEFLEX MEDICAL HZ APPLIER SMALL WIDE 8" CVD; APPLIER, SURGICAL, CLIP

Catalog Number 137082

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2017

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

During a coronary bypass operation the doctor found the clip had fallen off the applier.There was no patient injury.

Manufacturer Narrative

(b)(4).The dhr for the instrument in question, was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, inc.(b)(4) facility as part of a 100 piece lot in february of 2013.Evaluation of the returned instrument shows that the tips are slightly misaligned to each other in the closed position.Further evaluation revealed that although the tips are slightly misaligned to each other that this instrument picks-up, retains, closes and releases clips as required of its function.We are unable to validate the alleged complaint since we are unable to duplicate the alleged issue.All instruments were 100% visually inspected and function checked at time of manufacture as this is a standardized procedure at this facility.We are unable to determine what caused the tips to be slightly misaligned, but it is suspected that this instrument has been mishandled at some point at the customers facility since there are also knicks and dings on the outer jaw surfaces.No corrective action required at this time.Per fda guidelines for manufacturers which state: "manufacturers are 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.Manufacturers must other remarks: also report to the fda when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur." this incident is not reportable at this time with the information provided.

Event Description

During a coronary bypass operation the doctor found the clip had fallen off the applier.There was no patient injury.

• Brand Name: HZ APPLIER SMALL WIDE 8" CVD
• 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: 6669707
• MDR Text Key: 78471293
• Report Number: 3011137372-2017-00218
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 137082
• Device Lot Number: 06H1153149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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