MAUDE Adverse Event Report: TELEFLEX MEDICAL STAINLESS STEEL LIGATING CLIP APPLIERS; APPLIER, SURGICAL, CLIP

Model Number	IPN914955
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
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
Reported issue: reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.
Event or Problem Description
Reported issue: reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample has yet been received at tecomet facility for evaluation.Per customer provided information we are unable to perform a thorough device history review (dhr) for the alleged defective instrument since lot information has not been provided.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 instruments of this type are 100% function tested and visually inspected prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
Reported issue: reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.
Additional Manufacturer Narrative
Qn#(b)(4).At this time, the root cause is still unknown as the complaint investigation is pending completion from supplier, tecomet.The sample has not be returned to the supplier at time of this report.Per the complainant they are "taking clip appliers that are not functioning properly out of circulation." teleflex will reevaluate if a root cause is determined by supplier.As of now there is no root cause and no increase in risk level from hazard review estimate.No further action required.

• Brand Name: STAINLESS STEEL LIGATING CLIP APPLIERS
• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16452976
• Report Number: 3011137372-2023-00045
• Device Sequence Number: 17600985
• Product Code: GDO
• UDI-Device Identifier: 24026704710038
• UDI-Public: 24026704710038
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2023

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: 06E1870388
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 04/19/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/19/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown