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

Catalog Number 137081

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clips were not properly loaded into the jaws so that the user was unable to ligate adequately.Therefore, the applier was replaced with a new one.

Manufacturer Narrative

Qn#(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet inc.Kenosha facility as part of a 87pc.Lot in march of 2017.The returned instrument was evaluated and found that it picks up , retains , closed and releases clips as required of its function.We are unable to validate this complaint since we are unable to replicate the alleged issue.All instruments produced at this facility are 100% visually inspected and function tested prior to shipment to customer as this is a standardized procedure for this product line.

Event Description

It was reported that the clips were not properly loaded into the jaws so that the user was unable to ligate adequately.Therefore, the applier was replaced with a new one.

• Brand Name: HZ APPLIER SMALL 8" CVD
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8232126
• MDR Text Key: 132565655
• Report Number: 3011137372-2019-00016
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• 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: 06J1640731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1