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 Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

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 a clip got stuck in the applier and did not come out to be loaded while in use.Therefore, the device was replaced with a new one.No clip fell/remained in patient.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot # 73e1900520 was manufactured on (b)(6) 2019 a total of 288 pieces.Lot was released on (b)(6) 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 and a clip partially loaded incorrectly.The sample appears used as there is biological material present on the device.There is a buildup of biological material in the bottom jaw, specifically.Reference file anp1900075471 for investigation photos.First, the partially loaded clip was manually removed , and the trigger cycle was completed.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 was heard indicating that the internal ratchet ears are intact.The next clip was unable to properly load into the jaws as it did not latch onto the bottom jaw.The buildup of biological material in the bottom jaw was manually removed and another attempt was made to fire the device.This time, a clip was able to properly load into the jaws of the applier and was successfully applied to over-stressed tubing.The sample was received with 3 clips remaining, including the partially loaded clip, indicating that 12 clips were fired by the end user.The root cause of this complaint issue is the buildup of biological material in the bottom jaw.There were no functional issues found with the device itself.Therefore, based on the condition of the returned sample, unintentional user error caused or contributed to this event.Reference file anp1900075471 for investigation photos.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 stuck in applier" was confirmed based upon the sample received.Upon functional inspection, it was found that a buildup of biological material was stuck in the bottom jaw which prevented the clips from properly loading.Once the buildup was removed, the remaining clip was able to fire properly.There were no functional issues found with the device.Since the clips were unable to load due to the buildup of biological material in the jaw, unintentional user error caused or contributed to this event.

Event Description

It was reported that a clip got stuck in the applier and did not come out to be loaded while in use.Therefore, the device was replaced with a new one.No clip fell/remained in patient.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9716610
• MDR Text Key: 180132142
• Report Number: 3003898360-2020-00205
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• 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: 03/17/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1