MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML

Catalog Number AE05ML

Device Problems Failure to Advance (2524); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.The device history review for the product auto endo5 ml lot# 73j1800032 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clips do not open.They got stuck in the tip of the applier.

Event Description

It was reported that the clips do not open.They got stuck in the tip of the applier.

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 trigger partially engaged.The sample appears used as there is biological material present on the device.First, the trigger cycle was completed.Functional inspection was then 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 first clip was unable to properly load into the jaws as it was unable to latch onto the bottom jaw.Upon further examination, it was observed that there is a buildup of biological material in the bottom jaw which is preventing the clip from loading properly.The buildup 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.This was repeated with the same result for the remaining clips.The device was returned with 6 clips remaining in the channel, indicating that 9 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.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.One device 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 a buildup of biological material was stuck in the bottom jaw which prevented the first clip tested from properly loading.Once the buildup was removed, the remaining clips were able to fire properly.There were no functional issues found with the device.Since the first clip was unable to load due to the buildup of biological material in the jaw, unintentional user error caused or contributed to this event.

• Brand Name: AUTO ENDO5 ML
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8371147
• MDR Text Key: 137557890
• Report Number: 3003898360-2019-00198
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73J1800032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1