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

Catalog Number 137081

Device Problems Premature Activation (1484); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

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 problems.It was further reported that the clip fell from the applier jaws and into the patient and were retrieved.Other clips fell before use on the patient.There was no patient injury.

Manufacturer Narrative

(b)(4).Since lot information has not been provided, we are unable to determine where the alleged device was manufactured or perform a dhr review for this complaint.We did not receive a sample part and also did not receive any submitted pictures or video for us to perform an investigation therefore we are unable to validate the alleged complaint.

Event Description

It was reported that there were alignment problems.It was further reported that the clip fell from the applier jaws and into the patient and were retrieved.Other clips fell before use on the patient.There was no patient injury.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7118041
• MDR Text Key: 94883704
• Report Number: 3011137372-2017-00385
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 137081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1