MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML

Catalog Number AE05ML

Device Problems Activation, Positioning or Separation Problem (2906); Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73m1700112 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 the clip was crooked in the appliers and fell out.

Manufacturer Narrative

Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The sample was reviewed with a r & d engineer.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with the first clip out of position in the channel.The returned 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, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The first clip was unable to load properly into the jaws of the device.Another attempt was made and this time, the second clip was able to load properly and was successfully applied to over-stressed surgical tubing.This was repeated with the same result for the next three clips.On the following attempt, a dry fire occurred, where no clip fired.Another attempt was made and this time, the indicator clip fired.The sample was disassembled to inspect the internal components.No damages were observed.The first clip being out of position and the dry fire 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 5 clips remaining in the channel, indicating that 10 clips were fired by the end user.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 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 "clip fell from applier" was confirmed based upon the sample received.One device was returned with the first clip out of position in the channel.Upon functional inspection, the first clip was unable to load properly into the jaws of the device.Another attempt was made and this time, the second clip was able to load properly and was successfully applied to over-stressed surgical tubing.This was repeated with the same result for the next three clips.On the following attempt, a dry fire occurred, where no clip fired.Another attempt was made and this time, the indicator clip fired.The first clip being out of position and the dry fire 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 5 clips remaining in the channel, indicating that 10 clips were fired by the end user.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.

Event Description

It was reported that the clip was crooked in the appliers and fell out.

• Brand Name: AUTO ENDO5 ML
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8497027
• MDR Text Key: 141453358
• Report Number: 3003898360-2019-00415
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Catalogue Number: AE05ML
• Device Lot Number: 73M1700112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1