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 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73f1900184 investigation did not show issues related to the complaint.

Event Description

The jaws of the applier did not open so that the user was unable to ligate during surgery.Therefore, the device was replaced the with a new one.No clip fell/remained in the patient.

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 appears used as there is biological material present on the device.There is a buildup of biological material in the bottom jaw, specifically.The sample was returned with its trigger partially engaged and a clip loaded properly into the jaws.First, the 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 first 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.This was repeated with the same result for the remaining clips.The sample was received with 7 clips remaining, including the loaded clip, indicating that 8 clips were fired by the end user.The root cause of this complaint issue is the buildup of biologi cal 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." a corrective action is not required at this time as the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "jaws not opening completely" 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.The jaws would not "open completely" without the clips loading properly.Once the buildup was removed, the remaining clips were able to fire properly and the jaws functioned correctly.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

The jaws of the applier did not open so that the user was unable to ligate during surgery.Therefore, the device was replaced the with a new one.No clip fell/remained in the patient.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11585189
• MDR Text Key: 243363358
• Report Number: 3003898360-2021-00322
• 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: 03/18/2021

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: 06/04/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73F1900184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.