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

Catalog Number AE05ML

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73c1900605 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 during an operation, a clip got stuck in the applier and did not come out to be loaded.The user opened another unit of the same lot, however, the same issue occurred.He/she opened the other unit of the different lot, by which clips were loaded properly.No clip fell/remained in 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 mag nification.Visual examination of the returned device revealed that the sample was returned with its trigger partially engaged and with the rotation tab bent.A double feed was present as there were two closed clips stuck in the jaws and one of them was also stuck in the bent rotation tab.The sample appears used as there is biological material present on the device.Reference file anp1900073989 for investigation photos.First, the clips stuck in the jaws were manually removed and the trigger cycle was completed.It was observed that there was no clip in the next position of the channel.Functional inspection was then performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.No clip loaded on the first attempt.The next clip was out of position in the channel.Another attempt was made and again, no clip loaded.However, resistance was felt during the trigger pull.A clip with a broken hook and the broken hook fell out of the channel when the trigger cycle was completed.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another in the channel.The first feeder tab was bent due to the clip stacking.The sample was received with 13 clips remaining including the two clips that were stuck in the jaws, indicating that 2 clips were fired by the end user.The clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.Reference file anp1900073989 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." the clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.The reported complaint of "clip stuck in applier" was confirmed based upon the sample received.One device was returned with the rotation tab bent.A double feed was present as two clips were stuck in the jaws.It was observed that there was no clip in the next position.Upon functional inspection, no clip loaded on the first attempt.The next clip was out of position.On the second attempt, no clip loaded again but resistance was felt during the trigger pull.A clip with a broken hook and the broken hook fell out of the channel when the trigger cycle was completed.The sample was disassembled and it was found that the clips were out of position and stacking on one another.The first feeder tab was bent due to the clip stacking.The clip stacking prevented the clips from loading properly into the jaws.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.

Event Description

It was reported that during an operation, a clip got stuck in the applier and did not come out to be loaded.The user opened another unit of the same lot, however, the same issue occurred.He/she opened the other unit of the different lot, by which clips were loaded properly.No clip fell/remained in patient.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9483413
• MDR Text Key: 173223250
• Report Number: 3003898360-2019-01509
• 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: 12/05/2019

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: 03/04/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73C1900605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1