MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML

Catalog Number AE05ML

Device Problems Premature Activation (1484); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.The device history review for the product auto endo5 ml lot #73b1800287 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during a lap chole three different ae05ml failed in the same way.The jaws did not close all the way and thus the clips did not lock and fell into patient's abdomen.There was no patient injury.

Event Description

It was reported that during a lap chole three different ae05ml failed in the same way.The jaws did not close all the way and thus the clips did not lock and fell into patient's abdomen.There was no patient injury.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The sample is for this complaint tc and tc 1900060830.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.Reference file (b)(4) for investigation photos.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 properly load into the jaws of the applier and was successfully applied to over-stressed surgical tubing.This was repeated with the same result.The sample was received with 2 clips remaining in the channel indicating that 13 clips were fired by the end user.No defects or anomalies were observed.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." other remarks: the reported complaint of "jaws not closing" was not confirmed based upon the sample received.One device was returned.Upon functional inspection, no problems were found as clips could be loaded into the jaws and close with no issues.The jaws were able to open and close properly.The device was received with 2 clips remaining in the channel indicating that the end user fired 13 clips.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.No functional issues were found with the returned device.Additional method code: 26.

• Brand Name: AUTO ENDO5 ML
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7591344
• MDR Text Key: 111240190
• Report Number: 3003898360-2018-00405
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73B1800287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1