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

Catalog Number AE05ML

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clip flows into individual pieces without loading.

Event Description

It was reported that the clip flows into individual pieces without loading.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73e1800333 was manufactured on 05/15/2018 a total of (b)(4) pieces.Lot was released on 05/25/2018.Dhr investigation did not show issues related to complaint.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 and with a clip loaded properly into the jaws.Reference file (b)(4) for investigation photos.First, the clip was manually removed and the trigger cycle was completed.Functional inspection was then performed on the returned s ample 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 next 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 6 clips remaining including the clip returned loaded in the jaws, indicating that 9 clips were fired by the end user.No defects or anomalies were observed.Reference file (b)(4) for investigation photos.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 reported complaint could not be reproduced with the sample that was returned.The reported complaint of "loading issue" was not confirmed based upon the sample received.One device was returned.Upon functional inspection, no problems were found as all remaining clips were able to properly load into the jaws and were successfully applied to over-stressed surgical tubing.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.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9318351
• MDR Text Key: 170071226
• Report Number: 3003898360-2019-01318
• 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,u
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

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: 05/14/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1800333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1