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

Catalog Number 543965

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73f1800269 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 the clip was stuck in the applier and could not be released during usage on the patient.Then the doctor changed to hemolok clip.There was no patient harm.

Event Description

It was reported that the clip was stuck in the applier and could not be released during usage on the patient.Then the doctor changed to hemolok clip.There was no patient harm.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit 543965 autoendo5 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.The sample appears used as there is biological material present on the device.First, the trigger cycle was completed.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 first clip was able to load properly and was successfully applied to over-stressed surgical tubing.Another attempt was made and this time, the second clip was unable to load properly as it was unable to latch onto the bottom jaw.A buildup of biological material was observed in both jaws.The buildup was manually removed, and another attempt was made to fire the device.The third clip was unable to load properly.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.The sample was received with 6 clips remaining in the channel, indicating that 9 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 came out of position.A non-conformance has been opened to further investigate this issue.The ifu for this product, l03496, 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 came out of position.A nonconformance has been opened to further investigate the clip stacking issue.The reported complaint of "clip stuck in the applier" was confirmed based upon the sample received.Upon functional inspection, only one of the three clips tested were able to load properly into the jaws of the applier.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.The sample was received with 6 clips remaining in the channel, indicating that 9 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 came out of position.A non-conformance has been opened to further investigate this issue.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8611770
• MDR Text Key: 145106781
• Report Number: 3003898360-2019-00588
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K021808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/05/2019

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: 06/11/2021
• Device Catalogue Number: 543965
• Device Lot Number: 73F1800269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: 05/05/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1