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

Model Number IPN914947

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/17/2023

Event Type  Injury  

Manufacturer Narrative

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

Event 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 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.

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.

Manufacturer Narrative

(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.

Event 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.

• Brand Name: STAINLESS STEEL LIGATING CLIP APPLIERS
• Type of Device: 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: 16453394
• MDR Text Key: 310353456
• Report Number: 3011137372-2023-00048
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704709995
• UDI-Public: 24026704709995
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN914947
• Device Catalogue Number: 137112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention