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

Catalog Number 543965

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device history review for the product auto endo5 ml lot# 73d1800018 investigation did not show issues related to the complaint.The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the doctor opened the package and tried to test load but the clip was slipped from vessel, not loading.

Event Description

It was reported that the doctor opened the package and tried to test load but the clip was slipped from vessel, not loading.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit of 543965 autoendo5 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 the first clip protruding from the channel.The sample appears used as there is biological material present on the device.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 was unable to latch onto the bottom jaw.This was repeated with the same result for the second clip.Upon further examination, it was observed that there was a buildup of biological material in the bottom jaw which prevented the clip from loading properly.The buildup of biological material 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 surgical tubing.This was repeated with the same result for the remaining clips.The sample was received with 5 clips remaining in the channel indicating that 10 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, operational context caused or contributed to this event.The ifu for this product, l03496, 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 loading" 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 first two clips 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 two clips were unable to load due to the buildup of biological material in the jaw, operational context caused or contributed to this event.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8325951
• MDR Text Key: 135723796
• Report Number: 3003898360-2019-00142
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K021808
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 543965
• Device Lot Number: 73D1800018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1