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

Catalog Number 237081

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: the horizon medium clips tend to stick on the side of the horizon medium 8" open applier after ligating.This will prone to damage to a blood vessel such as vessel tear if user not aware while removing the applier after application.Cabg cardiac case.

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, wi facility as part of a 100-piece lot in august of 2018.Evaluation of the returned instrument shows that the light blue color coding on the ring is slightly faded.Further evaluation shows that there is visible damage to the outer jaw rail on one of the jaws.Functional evaluation using silastic test tubing shows that this instrument is able to pick-up, retain, close and release a clip without clip sticking to inner jaw surface thus we are unable to validate the alleged complaint since we were unable to replicate the alleged issue.We are unable to determine what caused the visible damage to the outer jaw rail on one of the jaws but mishandling at the end user's facility is suspected.All 50 instruments from the alleged lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for the product line.

Event Description

Reported issue: the horizon medium clips tend to stick on the side of the horizon medium 8" open applier after ligating.This will prone to damage to a blood vessel such as vessel tear if user not aware while removing the applier after application.Cabg cardiac case.

• Brand Name: HZ APPLIER MED 8" CVD
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10573486
• MDR Text Key: 208135645
• Report Number: 3011137372-2020-00201
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 237081
• Device Lot Number: 06J1756414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1