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

Model Number IPN914939

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Jaws are twisting and not holding the clips, when taking down ima (inferior mesenteric artery) in cardiac case, coronary artery bypass (cags).Damaged to the ima occurred.Latest incident occurred on friday (b)(6) 2021 but has been reported for the last 6 months.Refurbished replacement appliers were swapped over, however issue still occurred.Appliers sending back are from prior, will send remaining when received.Customer described damage as shredding of the ima.New clip applier was used until suitable, clipped above previously damaged area.Ima was still able to be harvested for bypass.Patient is fine, surgery was still successful.

Manufacturer Narrative

(b)(4).Per customer provided information the dhr for the alleged instrument was reviewed and found completely without any irregularities.The alleged instrument was produced at the (b)(6) as part of a 100 pc.Lot in june of 2012.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All 100 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.

Event Description

Jaws are twisting and not holding the clips, when taking down ima (inferior mesenteric artery) in cardiac case, coronary artery bypass (cags).Damaged to the ima occurred.Latest incident occurred on friday (b)(6) 2021 but has been reported for the last 6 months.Refurbished replacement appliers were swapped over, however issue still occurred.Appliers sending back are from prior, will send remaining when received.Customer described damage as shredding of the ima.New clip applier was used until suitable, clipped above previously damaged area.Ima was still able to be harvested for bypass.Patient is fine, surgery was still successful.

• Brand Name: HZ APPLIER SMALL WIDE 8" CVD
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12196515
• MDR Text Key: 262456607
• Report Number: 3011137372-2021-00187
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704709957
• UDI-Public: 24026704709957
• 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: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN914939
• Device Catalogue Number: 137082
• Device Lot Number: 06G1150940
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention