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

Catalog Number 544243

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product hemolok l clips 3/cart 42/box lot# 73c1900098 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

It was reported that (b)(6) 2020, in (b)(6), the boss of the clip was found broken prior to the patient after being uploaded for nephrectomy by doctor of thoracoscopic surgery.

Event Description

It was reported that 3rd mar 2020, in (b)(6), the boss of the clip was found broken prior to the patient after being uploaded for nephrectomy by doctor of thoracoscopic surgery.

Manufacturer Narrative

(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without mag nification.Visual examination of the returned device revealed that the sample was severely damaged near the distal end.Both jaws were bent and pushed into the outer tube.The channel box was severely bent and the jaw spring was disengaged from the jaws.A small piece of material which looks to be a piece of cardboard (probably scraped off the shipping box) was in the jaws/channel.The sample appears used as there is biological material present on the device.Functional inspection could not be performed due to the condition of the returned sample.However, the sample was disassembled to inspect the internal components.Upon disassembly, it was found that the ratchet ears were still intact.The clips were out of position and stacking on one another in the channel.The pusher head (distal end of the feeder) was broken off of the feeder.Additionally, the rotation tab was bent and curled inward which would block clips from advancing in the channel.The pivot holes where the jaws attach to the channel were found to be damaged as well.The sample was received with 7 clips remaining in the channel, indicating that 8 clips were fired by the end user.Based on the observed damages, it appears that the sample was dropped or pushed against something hard which caused the jaws to get pushed into the tube.With the jaws pushed into the tube, it seems that the sample was cycled a few times which led to the further damages to the device.Therefore, unintentional user error caused or contributed to this event.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." a corrective action is not required at this time as the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "applier does not work at all" was confirmed based upon the sample received.The sample was returned with the distal end severely damaged.Both jaws were bent and pushed into the outer tube, the channel box was severely bent, and the jaw spring was disengaged from the jaws.The sample was disassembled and the following damages were observed: clip stacking, distal end of feeder broken (pusher head), rotation tab severely bent, and pivot holes on channel damaged.A r & d engineer was consulted for this complaint investigation.Based on the observed damages, it appears that the sample was dropped or pushed against something hard which caused the jaws to get pushed into the tube.With the jaws pushed into the tube, it seems that the sample was cycled a few times which led to the further damages to the device.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.It is unlikely that this type of damage was present at the time of manufacturing.A device history record review was performed on the device with no evidence to suggest a manufacturing related defect.Therefore, based upon the observed damage, unintentional user error caused or contributed to this event.

• Brand Name: HEMOLOK L CLIPS 3/CART 42/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9866232
• MDR Text Key: 184621243
• Report Number: 3003898360-2020-00288
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2024
• Device Catalogue Number: 544243
• Device Lot Number: 73C1900098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1