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

Catalog Number AE05ML

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the 2nd clip was not loaded into the jaws properly during an operation.Therefore, the device was replaced with a new unit to complete the operation.

Manufacturer Narrative

(b)(4), per dhr the product auto endo5 ml lot # 73f1900184 was manufactured on 06/05/2019 a total of (b)(4) pieces.Lot was released on 06/13/2019.Dhr investigation did not show issues related to complaint.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 trigger partially engaged.There was a clip improperly loaded into the jaws and it was protruding out of the device against the rotation tab.The sample had its rotation tab bent.Biological material was observed on the channel.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, the trigger cycle was completed , and the improperly loaded clip fell from the device.The trigger was engaged again , and an audible ratchet sound could be heard indicating that the internal ratchet ears were intact.No clip loaded into the jaws.Another attempt was made , and the next clip was unable to properly load and fell out 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.The sample was received with 9 clips remaining in the channel indicating that 6 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 "clip(s) not loading properly" was confirmed based upon the sample received.The device was returned with its trigger partially engaged and its rotation tab bent.The sample was returned with 9 clips remaining in the channel indicating that 6 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.This prevented the clips from loading properly into the jaws of 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.

Event Description

It was reported that the 2nd clip was not loaded into the jaws properly during an operation.Therefore, the device was replaced with a new unit to complete the operation.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11101604
• MDR Text Key: 224774024
• Report Number: 3003898360-2020-01117
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73F1900184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1