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

Catalog Number 543965

Device Problems Unintended Movement (3026); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73g1800730 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 in the applier could not be closed into the vessel and then the clip loosened from the applier during usage on the patient for stomach cancer.After the applier came to lose of the clip there was a clip loosen into the patient, but it has been taken out.

Manufacturer Narrative

Qn# (b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint 3003898360-2019-01108 is being reported as a malfunction.There was no serious injury.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73g1800731 was manufactured on 07/24/2018 a total of (b)(4) pieces.Lot was released on 08/10/2018.Dhr investigation did not show issues related to complaint.The customer returned one unit 543965 autoendo5 ml for investigation.This sample is for tc 1900071577 & tc 1900071620.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample appears typical.Reference file (b)(4) for investigation photos.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, no audible ratchet sound could be heard indicating that the internal ratchet ears are broken.The first clip was able to load properly into the jaws and was successfully applied to over-stressed surgical tubing.This was repeated with the same result for the next clip.On the next attempt, no clip fired.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 6 clips remaining in the channel indicating that 9 clips were fired by the end user.One side of the top jaw also did not have the correct surface finish.This is a cosmetic issue and does not affect the functionality of the device.A non-conformance was previously opened to further investigate this issue.The broken ratchet caused the clips to become out of position and prevented the clips from properly loading into the jaws.It could not be determined what exactly caused the ratchet ears to break.A capa has been previously opened to further investigate loading and feeding issues.Reference file (b)(4) for investigation photos.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 broken ratchet prevented the clips from loading properly.It could not be determined what exactly caused the ratchet ears to break but a capa has been previously opened to further investigate loading and feeding issues.The reported complaint of "not closing" was confirmed based upon the sample received.Upon functional inspection, no clip fired on the third attempt.It was found that the clips were out of position and stacking on one another in the channel.The sample was received with 6 clips remaining in the channel indicating that 9 clips were fired by the end user.The broken ratchet caused the clips to become out of position and prevented the clips from properly loading into the jaws.Although the reported complaint was confirmed based on functional testing, it could not be determined what exactly caused the ratchet ears to break.A capa has been previously opened to further investigate loading and feeding issues.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8994898
• MDR Text Key: 157729931
• Report Number: 3003898360-2019-01108
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Catalogue Number: 543965
• Device Lot Number: 73G1800730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention