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

Catalog Number 523150

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported event: the jaw of the applier is hard and it is difficult to apply a clip into the applier.This issue happened prior to use on a patient.

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 (b)(6) facility as part of a 88pc.Lot in (b)(6) of 2015.Evaluation of the returned instrument showed that the tips are aligned properly in the open and closed position, but in the open position the tip gap is slightly undersized to print specifications and there are deep knicks on the face of the tip/jaw surface signifying some form of mishanding.Further evaluation showed that although the instruments tip/jaw gap is slightly undersized this instrument was able to pick up, retain, close and release clips as required of its function.We are unable to determine what caused the alleged defect at the customer's site although mishandling during the cleaning and sterilization process is suspected.No corrective action required.

Event Description

Reported event: the jaw of the applier is hard and it is difficult to apply a clip into the applier.This issue happened prior to use on a patient.

• Brand Name: HT APPLIER SMALL 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: 5667224
• MDR Text Key: 45527163
• Report Number: 3011137372-2016-00104
• 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: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2021
• Device Catalogue Number: 523150
• Device Lot Number: 06E1400143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: No
• 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