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 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73e1900683 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the first and second clip were ligated without a problem during an operation.However, the third clip and after were not loaded into the jaws properly in the patient body.Therefore, the device was replaced with a new one to complete the operation.No clip fell/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 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 able to load properly into the jaws but could not be applied to over-stressed surgical tubing since the jaws became misaligned.This was repeated with the same result for the next clip.On the following attempt, the indicator clip fired.The sample was disassembled in order to inspect the internal components.It was found that the bottom jaw was bent.The sample was received with 2 clips remaining in the channel, indicating that the end user fired 13 clips.The damage to the bottom jaw could prevent the clips from loading properly.It appears that an external force or side pressure was applied to the jaw, which caused it to bend.Therefore, based upon the damage observed, 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 "clips not loading properly" was confirmed based upon the sample received.Upon functional inspection, the clips were unable to be applied to over-stressed surgical tubing.It was found that the bottom jaw was bent.The observed damage to the jaw could prevent the clips from loading properly.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.It is unlikely that this type of damage was present at the time of manufacturing.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.Therefore, based upon the observed damage, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend reports of this nature.

Event Description

It was reported that the first and second clip were ligated without a problem during an operation.However, the third clip and after were not loaded into the jaws properly in the patient body.Therefore, the device was replaced with a new one to complete the operation.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: 10012147
• MDR Text Key: 189446803
• Report Number: 3003898360-2020-00392
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• 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: 73E1900683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1