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

Catalog Number AE05ML

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73b1900055 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 while unlocking the hem-o-lok applier the protective sheath got detached.

Event Description

It was reported that while unlocking the hem-o-lok applier the protective sheath got detached.

Manufacturer Narrative

(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its rotation tab bent and the first clip out of position in the channel.The returned sample appears used as there is biological material present on the device.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The first clip was unable to properly load into the jaws of the device.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.Additionally, the proximal end of the bridge was cracked , and the top jaw had slightly bent jaw legs.The sample was received with 6 clips remaining in the channel indicating that 9 clips were fired by the end user.A capa has been opened to further investigate this issue.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." although the root cause of this complaint issue could not be determined, a capa has been opened to further investigate the clip stacking issue.The reported complaint of "broken clip" was confirmed based upon the sample received.The device was returned with its rotation tab bent.The sample was returned with 6 clips remaining in the channel indicating that 9 clips were fired by the end user.Upon functional inspection, it was found that the clips were out of position and stacking on one another which prevented the clips from loading properly into the jaws of the device.The clip stacking can cause clips to break inside the device.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• MDR Report Key: 9156396
• MDR Text Key: 169863091
• Report Number: 3003898360-2019-01242
• 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,u
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73B1900055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1