MAUDE Adverse Event Report: TELEFLEX MEDICAL HT APPLIER MED 8" CVD; APPLIER,SURGICAL, CLIP

Catalog Number 523110

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

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

The applier could not hold clips firmly because the jaws of applier had loose alignment.There was no patient injury.

Manufacturer Narrative

(b)(4).The dhr for the lot number provided was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, inc.Kenosha facility as part of a (b)(4) lot in march of 2015.Since the instrument was not returned for evaluation we are unable to validate these complaints or determine root cause.All instruments are thoroughly inspected and function tested at time of manufacture.No corrective action required at this time.

Event Description

The applier could not hold clips firmly because the jaws of applier had loose alignment.There was no patient injury.

• Brand Name: HT APPLIER MED 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: 6717223
• MDR Text Key: 80178933
• Report Number: 3011137372-2017-00236
• 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: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 523110
• Device Lot Number: 06B1498546
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• 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