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

Model Number	IPN914955
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem 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.
Event or Problem 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.
Additional Manufacturer Narrative
Qn# (b0(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 tecomet, inc.Kenosha wi facility as part of a 87 pc.Lot in september of 2015.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 87 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.

• Brand Name: HZ APPLIER MED 8" CVD
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12196626
• Report Number: 3011137372-2021-00182
• Device Sequence Number: 3509405
• Product Code: GDO
• UDI-Device Identifier: 24026704710038
• UDI-Public: 24026704710038
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN914955
• Device Catalogue Number: 237081
• Device Lot Number: 06J1407731
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention