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

Catalog Number AE05ML

Device Problems Difficult to Open or Close (2921); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73f1800730 investigation did not show issues related to the complaint.The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

The clip did not open, and it slipped or fell.

Manufacturer Narrative

Qn#(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 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, no audible ratchet sound could be heard indicating that the internal ratchet ears are broken.The first clip was unable to properly load into the jaws and had its hook broken off.After the first clip fired, the second clip was protruding from the channel and the third clip was also out of position in the channel.The sample was disassembled to inspect the internal components.Upon disassembly, it was confirmed that the clips were out of position in the channel and stacking on one another.The broken ratchet caused the clips to become out of position and prevented the clips from properly loading into the jaws.The sample was received with 7 clips remaining in the channel indicating that 8 clips were fired by the end user.It could not be determined what exactly caused the ratchet ears to break but a nonconformance 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." the reported complaint of "clip did not load properly" was confirmed based upon the sample received.One device was returned.The device was received with 7 clips remaining in the channel indicating that 8 clips were fired by the end user.Upon functional inspection, the first clip was unable to fire properly and was found to be broken at the hook.Upon disassembly of the device, it was found that the clips were out of position in the channel and stacking on one another.The ratchet ears were found to be broken and was the root cause of the clips becoming out of position.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.

Event Description

The clip did not open, and it slipped or fell.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8592029
• MDR Text Key: 144460968
• Report Number: 3003898360-2019-00513
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73F1800730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1