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

Catalog Number AE05ML

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

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

Surgeon has been using ae05 and is familiar with product's operation technique.Supposedly midway through operation product failed and jammed.So ae05 device was aborted for safety reason.Faulty product is returned for investigation and surgeon wants monetary refund and report of investigation.

Event Description

Surgeon has been using ae05 and is familiar with product's operation technique.Supposedly midway through operation product failed and jammed.So ae05 device was aborted for safety reason.Faulty product is returned for investigation and surgeon wants monetary refund and report of investigation.

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.Revision of fmea-08-029 rev 04 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

Event Description

Surgeon has been using ae05 and is familiar with product's operation technique.Supposedly midway through operation product failed and jammed.So ae05 device was aborted for safety reason.Faulty product is returned for investigation and surgeon wants monetary refund and report of investigation.

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 its rotation tab bent.The sample appeared used as there was biological material on the device.There was biological material found in the jaws in the sample.Functional inspection was performed by applying hand pressure to the trigger.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the ratchet ears are intact.The first clip did not load properly into the jaws.The jaws were partially closed at the end of the trigger cycle.A second attempt was made , and the next clip was also unable to load properly.A third attempt was made , and this clip was able to properly load into the jaws.This clip was able to successfully fire onto over-stressed surgical tubing.The indicator clip was seen in the channel indicating that there were no more clips remaining.The sample was disassembled to inspect the internal components.Upon disassembly, no other damages were observed.There was a significant amount of biological material found on the channel and feeder.The bent rotation tab and clip misfires are indications that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 3 clips remaining indicating that 12 clips were fired by the end user.A capa 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 bent rotation tab and clip misfires are indications that clip stacking occurred.A capa has been opened to further investigate the clip stacking issue.The reported complaint of "jamming - clip(s) not firing" was confirmed based upon the sample received.The device was returned with its rotation tab bent and 3 clips remaining in the channel indicating that 12 clips were fired by the end user.The first two clips were unable to properly load into the jaws of the device.The last clip remaining was able to properly load into the jaws and successfully fire onto over-stressed surgical tubing.The bent rotation tab and clip misfires are indications that the clips were out of position and stacking on one another.This could prevent the clips from loading properly into the jaws of the device.It could not be determined what exactly caused the clips to become out of position.A capa has been opened to further investigate this issue.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11030486
• MDR Text Key: 222375269
• Report Number: 3003898360-2020-01058
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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: 12/21/2020
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1