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

Catalog Number AE05ML

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73e1900682 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 a clip was not loaded properly during a laparoscopic enterectomy.Also, some clips slipped off the vessel at ligation.Therefore, the device was replaced with a new one to complete the operation.All the fallen clips were withdrawn so that no clip remained in the patient.

Manufacturer Narrative

(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 rotation tab bent and its trigger partially engaged.A clip was partially loaded incorrectly.The returned sample appears used as there is biological material present on the device.First, the partially loaded clip was manually removed and the trigger cycle was completed.The next clip was slightly out of position in the channel.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 next clip was unable to properly load.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 6 clips remaining, including the partially loaded clip, 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." the reported complaint of "clip not loaded properly" was confirmed based upon the sample received.The device was returned with its rotation tab bent and a clip partially loaded incorrectly.The sample was returned with 6 clips remaining, including the partially loaded clip, 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.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 a clip was not loaded properly during a laparoscopic enterectomy.Also, some clips slipped off the vessel at ligation.Therefore, the device was replaced with a new one to complete the operation.All the fallen clips were withdrawn so that no clip remained in the patient.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9884829
• MDR Text Key: 185661638
• Report Number: 3003898360-2020-00334
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1900682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 04/09/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1