MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Model Number IPN028126

Device Problem Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the clip loaded properly on applier but did not close/locked on tissue even after several attempts.This occurred on several devices.

Manufacturer Narrative

(b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot# 73e1900059 was manufactured on (b)(6) 2019 a total of 15,456 pieces.Lot was released on (b)(6) 2019.Dhr investigation did not show issues related to complaint.P/n (b)(4) is not being manufactured currently, however, another part number from the same family was use for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 13 samples were taken from the current production p/n (b)(6) hemolok l clips 6/cart 84/box, lot# 73m2000539, the samples were functionally inspected, and during the test issue reported "clips not closing/locking" was not observed in the current manufacturing process.Revision of fmea-08-025 rev 05 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.

Event Description

It was reported that the clip loaded properly on applier but did not close/locked on tissue even after several attempts.This occurred on several devices.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9666557
• MDR Text Key: 177961029
• Report Number: 3003898360-2020-00190
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K133202
• 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: 02/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: IPN028126
• Device Catalogue Number: 544230
• Device Lot Number: 73E1900059
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1