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

Catalog Number 544253

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 xl clips 3/cart 42/box lot# 73b1900018 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 the doctor.

Manufacturer Narrative

Qn#(b)(4).The customer returned one loose clip 544250 hemolok xl clips 6/cart 84/box for investigation.A loose clip was returned with broken pierced bosses and pierced leg-tip.The broken pierced bosses and pierced leg-tip were not returned.The sample appears used as there is biological material on the cartridge.The appliers were not returned.The observed damage appears to be consistent with improper loading of the clips or use of damaged appliers.Functional inspection could not be performed due to the condition of the returned clip.The ifu for this product, l06110, was reviewed as a part of this complaint investigation.The ifu states the following: "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 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.It may be necessary to hold the cartridge to allow the clip to be removed."."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.".A corrective action is not required at this time as the damage observed on the returned clip indicates that unintentional user error caused or contributed to this event.However, it could not be determined exactly how the clip broke.The reported complaint of "broken/detached parts - clip - boss" was confirmed based upon the sample received.A loose clip was returned with broken pierced bosses and pierced leg-tip.The broken pierced bosses and pierced leg-tip were not returned.The observed damage to the clip appears to have been caused by improper loading of the clips or use of damaged appliers.It is unknown how the returned clip was handled during use and the appliers used at the time of malfunction were not returned for investigation.The ifu advises on proper loading technique including avoiding forcing the applier into cartridge or the clip.The ifu also advises to inspect applier jaws prior to use and ensure regular maintenance.A device history record review was performed and showed no evidence to suggest a manufacturing related issue.It is unlikely that the damage was present when the sample left the manufacturing site.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend reports of this nature.

Event Description

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

• Brand Name: HEMOLOK XL CLIPS 3/CART 42/BOX
• Type of Device: CLIP,IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9866304
• MDR Text Key: 184621103
• Report Number: 3003898360-2020-00287
• 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: 01/31/2024
• Device Catalogue Number: 544253
• Device Lot Number: 73B1900018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1