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 12/10/2019

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 customer tried to load clip and clamped the handle but the clip did not load.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73e1900523 was manufactured on 05/21/2019 a total of (b)(4) pieces.Lot was released on 05/29/2019.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 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 clip was partially loaded incorrectly into the jaws.The sample appears used as there is biological material present on the device.Reference file anp1900074067 for investigation photos.First, the partially loaded clip was manually removed and the trigger cycle was completed.A broken hook could be seen in the channel.The next clip was also out of position.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 it had a broken hook.The following clip was protruding from the channel.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 9 clips remaining including the partially loaded clip, indicating that 6 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.Referencefile anp1900074067 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 "clips not loading properly" was confirmed based upon the sample received.One device was returned with the rotation tab bent and a clip partially loaded incorrectly.Upon functional inspection, the clip was unable to load properly as it had a broken hook.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.

Event Description

It was reported that the customer tried to load clip and clamped the handle but the clip did not load.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9490070
• MDR Text Key: 173228069
• Report Number: 3003898360-2019-01561
• 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: 12/16/2019

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: 05/20/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1900523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1