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 report 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, we confirmed no clips fell into the patient.

Manufacturer Narrative

(b)(4).Additional method code: the dhr for the instrument in question, was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(6).Lot in (b)(6) of 2014.Evaluation of the returned instrument showed that the tips are aligned properly with each other and the instrument properly picks-up, retains, closes and releases multiple clips as required of its function.At this time we are unable to validate the alleged complaint since we are unable to replicate 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.No corrective action required at this time.

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, we confirmed no clips fell into the 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: 5667267
• MDR Text Key: 45527315
• Report Number: 3011137372-2016-00105
• 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 Catalogue Number: 523150
• Device Lot Number: 06B1379252
• 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