MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML

Catalog Number AE05ML

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device history review for the product auto endo5 ml lot #73l1800547 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 clips got stuck in the applier; they will not come out.

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 appears used as there is biological material present on the device.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 of the applier and was successfully applied to over-stressed surgical tubing.The next clip was unable to load properly into the jaws as the clip was located to the side of the pusher head (distal end of feeder).The indicator clip was in the next position.On the next attempt, the indicator clip fired indicating that no clips were remaining in the channel.The device was disassembled to inspect the internal components.The proximal end of the feeder was slightly bent.The proximal end of the bridge was also bent.The device was received with 2 clips remaining in the channel indicating that 13 clips were fired by the end user.The clip mis-load and the damages to the feeder and the bridge are indications that the clips were out of position and stacking on one another.The broken ratchet caused the clips to come out of position and prevented the clips from loading properly into the jaws.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.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 broken ratchet caused the clips to come out of position and prevented the clips from loading properly into the jaws.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.The reported complaint of "clip got stuck in the applier" was confirmed based upon the sample received.One device was returned.The device was received with 2 clips remaining indicating that 13 clips were fired by the end user.Upon functional inspection, the first clip was able to load properly into the jaws of the applier and was successfully applied to over-stressed surgical tubing.The next clip was unable to load properly into the jaws as the clip was located to the side of the pusher head (distal end of feeder).The device was disassembled to inspect the internal components.The proximal end of the feeder was slightly bent.The proximal end of the bridge was also bent.The device was received with 2 clips remaining in the channel indicating that 13 clips were fired by the end user.The clip mis-load and the damages to the feeder and the bridge are indications that the clips were out of position and stacking on one another.The broken ratchet caused the clips to come out of position and prevented the clips from loading properly into the jaws.It could not be determined what exactly caused the ratchet ears to break but nc 70018423 has been opened to further investigate this issue.The reported complaint of "clip got stuck in the applier" was confirmed based upon the sample received.One device was returned.The device was received with 2 clips remaining indicating that 13 clips were fired by the end user.Upon functional inspection, the first clip was able to load properly into the jaws of the applier and was successfully applied to over-stressed surgical tubing.The next clip was unable to load properly into the jaws as the clip was located to the side of the pusher head (distal end of feeder).The device was disassembled to inspect the internal components.The proximal end of the feeder was slightly bent.The proximal end of the bridge was also bent.The device was received with 2 clips remaining in the channel indicating that 13 clips were fired by the end user.The clip mis-load and the damages to the feeder and the bridge are indications that the clips were out of position and stacking on one another.The broken ratchet caused the clips to come out of position and prevented the clips from loading properly into the jaws.It could not be determined what exactly caused the ratchet ears to break but a nonconformance has been opened to further investigate this issue.

Event Description

It was reported that clips got stuck in the applier; they will not come out.

• Brand Name: AUTO ENDO5 ML
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8709378
• MDR Text Key: 148972165
• Report Number: 3003898360-2019-00659
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• 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: 05/21/2019

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: 11/18/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73L1800547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1