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

Catalog Number 137081

Device Problems Failure to Align (2522); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2017

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

It was reported that there were alignment issues.There is a problem in closing the clip because of alignment issues.There was no patient injury.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.The device history review for the alleged instrument was reviewed and found complete without any irregularities.We are unable to validate the alleged complaint at this time.The root cause is unknown.Teleflex will continue to monitor and trend related events.

• Brand Name: HZ 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 7044647
• MDR Text Key: 93007862
• Report Number: 3011137372-2017-00370
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 137081
• Device Lot Number: 06A1378339
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• 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