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

Catalog Number AE05ML

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73l1800544 investigation did not show issues related to the complaint.The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that two clips fired off as normal.When firing the third clip no clip was present.Then upon subsequent firing clips were falling out.This was replicated on the two samples.

Manufacturer Narrative

Qn#(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 the rotation tab bent and the indicator clip in the first position of the channel.Functional inspection was 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 indicator clip fired on the first attempt indicating that no clips were remaining in the channel.The sample was disassembled to inspect the internal components.The yoke was broken at the pin position.Scrape marks were also observed on the inside of the yoke.One end of the feeder spring appears to be incorrectly formed.The feeder tab on the proximal end of the feeder was severely bent.The proximal end of the bridge was also bent.The distal end of the feeder was also bent.The sample was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.The damages to the yoke, the feeder and the bridge are indications that the feeder spring bound up internally in the yoke which resulted in the feeder tab being bent and shortened the overall stroke of the feeder.This resulted in the clips not being able to properly load as they were unable to advance all the way forward in the jaws.It was determined that the feeder spring getting bound up in the yoke was the root cause of this issue and prevented the clips from loading properly.This is a manufacturing related issue.A nonconformance was previously opened to further investigate this issue.Corrective actions have been put in place to help prevent this issue from recurring.The received sample was manufactured prior to the corrective actions being put in place.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 "clips falling" was confirmed based upon the sample received.One device was returned with the rotation tab bent and the indicator clip in the first position of the channel indicating that no clips were remaining in the channel.The sample was disassembled to inspect the internal components.The yoke was broken at the pin position.Scrape marks were also observed on the inside of the yoke.One end of the feeder spring appears to be incorrectly formed.The feeder tab on the proximal end of the feeder was severely bent.The proximal end of the bridge was also bent.The distal end of the feeder was also bent.The sample was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.The defects and damages observed on the yoke, the feeder, feeder spring and the bridge are indications that the feeder spring bound up internally in the yoke which resulted in the feeder tab being bent and shortened the overall stroke of the feeder.This resulted in the clips not being able to properly load as they were unable to advance all the way forward in the jaws.It was determined that the feeder spring getting bound up in the yoke was the root cause of this issue and prevented the clips from loading properly.This is a manufacturing related issue.A nonconformance was previously opened to further investigate this issue.Corrective actions have been put in place to help prevent this issue from recurring.The received sample was manufactured prior to the corrective actions being put in place.

Event Description

It was reported that two clips fired off as normal.When firing the third clip no clip was present.Then upon subsequent firing clips were falling out.This was replicated on the two samples.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8708209
• MDR Text Key: 148309868
• Report Number: 3003898360-2019-00689
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73L1800544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1