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

Model Number	IPN028188
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Received call from senior staff nurse to be advised that during a coronary artery bypass graft they had a number of clip failures (10+).The nurse was not in the case so she is unaware of how it was resolved.She believes that the patient's condition is okay.The nurse is going to confirm the lot number of the clips used and is requesting for the appliers to be decontaminated and quarantined.I have arranged to go in wednesday to inspect the appliers and gather further details from surgical team.I am advised photos were taken and the clinical lead was called in to observe the issue.The appliers were new appliers.They have been used only during the past 3 week.I will be able to identify how many times they have been processed after wednesday.Clinical consequences: medical intervention was necessary due to the alleged issue.Additional information: it is probable that sutures were needed to ligate the vessel properly but she is waiting for confirmation from the surgeon.She collected 5 cartridges of representative clips and the appliers.All four of the medium appliers would have been used during the procedure but she could not say which one if any was responsible for the problem.She inspected them visually and could not observe any default.The small appliers were collected by the sales representative but they are not relevant to this complaint.
Additional Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
(b)(4).The dhr for the returned device was reviewed and found completely without any irregularities.This device was produced at the tecomet, inc.Kenosha wi facility as part of a 100 piece lot in august of 2020.Evaluation of the returned instrument shows that the tips are aligned in the open and closed position and that this instrument is able to pick-up, retain, closed and release multiple clips both with and without the use of silastic test tubing.Further evaluation using this instrument to close 5 clips shows that maximum eye gap specification of.0073 measured at (.0019-.0034 max.) and the maximum leg gap specification of.0060 measured at (.0035-.0042 max.) verifying that this instrument performs as designed.We were unable to find any nonconforming features on this device therefore we are unable to validate this complaint.We are unable to determine what caused the alleged defect at the end user's facility.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 or Problem Description
Received call from senior staff nurse to be advised that during a coronary artery bypass graft they had a number of clip failures (10+).The nurse was not in the case so she is unaware of how it was resolved.She believes that the patient's condition is okay.The nurse is going to confirm the lot number of the clips used and is requesting for the appliers to be decontaminated and quarantined.I have arranged to go in wednesday to inspect the appliers and gather further details from surgical team.I am advised photos were taken and the clinical lead was called in to observe the issue.The appliers were new appliers.They have been used only during the past 3 week.I will be able to identify how many times they have been processed after wednesday.Clinical consequences: medical intervention was necessary due to the alleged issue.Additional information: it is probable that sutures were needed to ligate the vessel properly but she is waiting for confirmation from the surgeon.She collected 5 cartridges of representative clips and the appliers.All four of the medium appliers would have been used during the procedure but she could not say which one if any was responsible for the problem.She inspected them visually and could not observe any default.The small appliers were collected by the sales representative but they are not relevant to this complaint.

• Brand Name: HZ APPLIER MED 8" CVD
• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville 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: 13915905
• Report Number: 3011137372-2022-00038
• Device Sequence Number: 3883473
• Product Code: GDO
• UDI-Device Identifier: 24026704710038
• UDI-Public: 24026704710038
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN028188
• Device Catalogue Number: 237081
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/26/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown