MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number AE05ML

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73e1900520 investigation did not show issues related to complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the jaws of the applier was found bent when the user tried to load a clip during a operation.Therefore, the device was replaced the with a new one.

Event Description

It was reported that the jaws of the applier was found bent when the user tried to load a clip during a operation.Therefore, the device was replaced the with a new one.

Manufacturer Narrative

Qn#(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 returned with its trigger partially engaged and its rotation tab bent.A clip with a broken hook was stuck in the bent rotation tab.The top jaw was bent.The sample appeared used as there is biological material on the device.First, the partially loaded clip was removed and the trigger cycle was completed.After the trigger cycle was completed, the jaw spring disengaged and protruded from the channel.No clip was in the next position in the channel.Functional inspection was not performed since the bent jaw and disengaged jaw spring would prevent clips from firing properly.However, the sample was disassembled to inspect the internal components.Upon disassembly, it was confirmed that the internal ratchet ears were intact.The top jaw and jaw spring were both bent.The clips were found to be out of position in the channel and stacking on one another.The sample was received with 10 clips remaining, including the partially loaded clip, indicating that 5 clips were fired by the end user.The channel pivot hole where the top jaw attaches to the channel was also found to be damaged.The bent jaw would prevent the clips from loading properly and could also cause the clips to get out of position in the channel and the jaw spring to disengage.The damage to the top jaw appears to have occurred during use.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 "bent/deformed parts - jaw" was confirmed based upon the sample received.One device was returned with its top jaw bent.In addition to the top jaw being bent, the following defects were observed, all of which could be caused by the jaw being bent: clip stacking, bent and disengaged jaw spring, bent rotation tab, broken clip, and damaged pivot hole on the channel.The sample was received with 10 clips remaining, including the partially loaded clip, indicating that 5 clips were fired by the end user.The bent top jaw on the channel prevented the clips from loading properly and could also cause the clips to get out of position in the channel, leading to further damages.A device history record review was performed on the autoend05 with no evidence to suggest a manufacturing related cause.The damage to the top jaw appeared to have occurred during use.Therefore, unintentional user error caused or contributed to this event.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10138231
• MDR Text Key: 194643416
• Report Number: 3003898360-2020-00477
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152081
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1900520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1