MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK XL CLIPS 3/CART 42/BOX; CLIP,IMPLANTABLE

Catalog Number 544253

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2020

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 on (b)(4) 2020, in (b)(6) hospital in (b)(6), the clip could not be closed properly during usage on the patient.

Manufacturer Narrative

Qn# (b)(4).Per dhr the product hemolok xl clips 3/cart 42/box lot# 73h1800273 was manufactured on 08/14/2018 a total of (b)(4) pieces.Lot was released on 08/23/2018.Dhr investigation did not show issues related to complaint.A verification of failure mode reported in the current manufacturing process was conducted as follows: 13 samples were taken from the current production p/n 544253 hemolok xl clips 3/cart 42/box lot# 73m2000254, the samples were functionally inspected, and during the inspection issue reported "ligation failure - info not provided" was not observed in the current manufacturing process.Revision of (b)(6) 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.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

Event Description

It was reported that on (b)(6) 2020, in (b)(6) hospital in (b)(6), the clip could not be closed properly during usage on the patient.

• Brand Name: HEMOLOK XL CLIPS 3/CART 42/BOX
• Type of Device: CLIP,IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11031527
• MDR Text Key: 222375919
• Report Number: 3003898360-2020-01051
• 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: 12/16/2020

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: 08/13/2023
• Device Catalogue Number: 544253
• Device Lot Number: 73H1800273
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1