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

Catalog Number AE05ML

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73e1900345 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 when the user tried to load a clip outside the patient's body during an operation, a spring popped out from the jaws.Therefore, the device was replaced with a new one.

Event Description

It was reported that when the user tried to load a clip outside the patient's body during an operation, a spring popped out from the jaws.Therefore, the device was replaced with a new one.

Manufacturer Narrative

(b)(4).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 the rotation tab bent.A clip with a broken hook was partially loaded incorrectly and was stuck in the bent rotation tab.The sample appears used as there is biological material present on the device.Reference file (b)(4) for investigation photos.First, the partially loaded clip was manually removed , and the trigger cycle was completed.It was observed that the next clip was out of position in 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.The next clip was unable to load properly as the feeder was to the side of the clip.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 sample was received with 7 clips remaining in the channel, indicating that 8 clips were fired by the end user.The clip stacking prevented the clips from loading properly into the jaws.The clip stacking can also cause the clips to break in the channel, as observed with this sample.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 anp (b)(4) for investigation photos.First, the partially loaded clip was manually removed , and the trigger cycle was completed.It was observed that the next clip was out of position in the channel.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 reported complaint of "spring popped out from jaws" was confirmed based upon the sample received.One device was returned with the rotation tab bent.A clip with a broken hook was partially loaded incorrectly and was stuck in the bent rotation tab.Upon functional inspection, the next clip was unable to load properly as the feeder was to the side of the clip.The sample was disassembled , and it was found that the clips were out of position and stacking on one another.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.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9699408
• MDR Text Key: 179415515
• Report Number: 3003898360-2020-00196
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1900345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1