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

Catalog Number 523110

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The clip appliers are no longer holding clips correctly.Clips are falling out of the appliers; no clips fell inside the patient.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The dhr for the instrument in question was reviewed and there were no irregularities found.This instrument was manufactured by teleflex medical as part of a (b)(4) pc.Lot in february of 2008.The complaint sample was not received for investigation therefore the reported defect cannot be verified.The dhr for the instrument in question was reviewed and there were no irregularities found.

Event Description

The clip appliers are no longer holding clips correctly.Clips are falling out of the appliers; no clips fell inside the patient.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Evaluation of the returned instruments showed that the tips are aligned properly with each other both in the open and closed position, but both tips are damaged.Further evaluation of the returned instrument showed that although the tips are aligned properly this instrument picks-up but will not retain a clip as required thus validating this complaint.Further analysis determined that the tip set is currently oversized on the sample.At this time we are unable to determine as to what caused the tips to be damaged or the alleged failure of this instrument in the field although mishandling at the customers facility is suspected.All instruments were 100% visually inspected and function tested at the time of manufacture as this is a standardized procedure at this facility.No corrective action required at this time.

Event Description

The clip appliers are no longer holding clips correctly.Clips are falling out of the appliers; no clips fell inside the patient.The patient's condition was reported as fine.

• 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: 6314478
• MDR Text Key: 67211444
• Report Number: 3011137372-2017-00014
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 523110
• Device Lot Number: 3649556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• 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