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

Catalog Number 544230

Device Problem Material Integrity Problem (2978)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device history review for the product hemolok ml clips 6/cart, 84/box, lot# 73d2000174.Investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

After ligating a clip, the user found a green fragment of about 1 mm at the ligated area and picked it up.The user would like us to investigate whether the fragment is part of the clip.No health injury to the patient was reported.Additional information: the green fragment was found right next to the ligated clip.The user picked it up with forceps.

Manufacturer Narrative

(b)(4).The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The cartridge was returned with only one clip remaining.The cartridge was visually examined with and without magnification.Visual examination revealed that the sample appears used as there was biological material on the cartridge.The customer reported that a green fragment was found, however no green fragment was returned.There were multiple small scrape marks found on the cartridge.Dimensional inspection was not required as a part of this complaint investigation.Functional inspection was performed on the one clip remaining in the cartridge.An attempt was made to load the clip into a lab inventory clip applier.The clip was successfully able to load into the applier and fire onto over-stressed surgical tubing.No issues were found with the returned clip.The multiple scrape marks observed on the cartridge indicate that the appliers were inappropriately used when attempting to load the clip.This is likely what caused a green fragment to be found by the end user as a fragment from the cartridge could have stuck to the clip/appliers and then fell off at the ligation site.It is also possible that the end user was using misaligned or damaged appliers, however this could not be confirmed as the appliers were not returned for investigation.Therefore, it appears that unintentional user caused or contributed to this event.The device history review for the product hemolok ml clips 6/cart 84/box lot# 73d2000174 was manufactured on 04/07/2020 a total of (b)(4) pieces.Lot was released on 04/15/2020.Dhr investigation did not show issues related to the complaint.The ifu for this product, l02425, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." "to load the applier, grasp the applier and carefully insert the jaws of the applier into the cartridge slot, making sure the jaws are perpendicular to the base of the cartridge.Gently press the applier over the clip until there is an audible double click.Do not force the applier into the cartridge or onto the clip.The applier should enter and withdraw from the cartridge easily.Remove the applier from the cartridge ensuring the clip is held securely in the applier jaws.The clip bosses should seat in the notches of the applier jaw.It may be necessary to hold the cartridge to allow the clip to be removed.".A corrective action is not required at this time as the damage observed indicates that unintentional user error caused or contributed to this event.The reported complaint of "broken/detached parts - cartridge" was confirmed based upon the sample received.The cartridge was returned with one clip remaining.Although no green fragment was returned, there were multiple scrape marks observed on the returned cartridge.The remaining clip was able to properly load into appliers and fire onto over-stressed surgical tubing.The observed damage on the cartridge is consistent with improper loading of the clips as the scrape marks indicate that the appliers were inappropriately used when attempting to load the clips.It is possible that the end user was using misaligned or damaged appliers, however the appliers were not returned for investigation.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.

Event Description

After ligating a clip, the user found a green fragment of about 1 mm at the ligated area and picked it up.The user would like us to investigate whether the fragment is part of the clip.No health injury to the patient was reported.Additional information: the green fragment was found right next to the ligated clip.The user picked it up with forceps.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12031465
• MDR Text Key: 257178191
• Report Number: 3003898360-2021-00568
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544230
• Device Lot Number: 73D2000174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1