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

Catalog Number 544230

Device Problem Break (1069)

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

Event Date 11/21/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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)(6) 2020, in (b)(6), the clip was broken during uploading for intestinal resection changing the clip and the applier the clip was loaded successfully and the treatment was performed successfully.The patient was fine.And it was confirmed that the clip broken was caused by the misaligned jaw of the applier while it was not confirmed whether the imported, or domestic applier was used in the event.The suggestion of using the imported applier has been made to the customer, and they accepted.

Manufacturer Narrative

Qn# (b)(4).Per dhr the product hemolok ml clips 6/cart 84/box lot# 73a1900465 was manufactured on 01/15/2019 a total of (b)(4) pieces.Lot was released on 01/31/2019.Dhr investigation did not show issues related to complaint.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 the (b)(6), the clip was broken during uploading for intestinal resection changing the clip and the applier the clip was loaded successfully and the treatment was performed successfully.The patient was fine.And it was confirmed that the clip broken was caused by the misaligned jaw of the applier while it was not confirmed whether the imported or domestic applier was used in the event.The suggestion of using the imported applier has been made to the customer and they accepted.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11030733
• MDR Text Key: 222337057
• Report Number: 3003898360-2020-01041
• 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: 12/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Catalogue Number: 544230
• Device Lot Number: 73A1900465
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1