MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML

Catalog Number AE05ML

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73d1800210 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 during the operative process of ligation of the clip came out closed without being used.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.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.No clip fired.Another attempt was made and, this time, the indicator clip fired which indicates that no more clips were remaining in the device.The broken rotation tab and dry fire are both indications that the clips were out of position and stacking on one another in the channel.The clip stacking could prevent the clips from properly loading into the jaws and could also cause the ratchet ears to break.The sample was received with 0 clips remaining in the channel indicating that 15 clips were fired by the end user.Non-conformance 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 reported complaint of "clips coming out closed" was confirmed based upon the sample received.One device was returned with its rotation tab broken.The device was received with 0 clips remaining in the channel indicating that 15 clips were fired by the end user.Upon functional inspection, a dry fire occurred on the first attempt before the indicator clip fired on the second attempt.The dry fire and broken rotation tab are both indications that the clips were out of position and stacking on one another which could prevent the clips from loading properly into the jaws of the device.It was also found that the ratchet ears were broken which could occur due to a clip stack.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.Non-conformance has been opened to further investigate this issue.

Event Description

It was reported that during the operative process of ligation of the clip came out closed without being used.

• Brand Name: AUTO ENDO5 ML
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7996414
• MDR Text Key: 124955992
• Report Number: 3003898360-2018-00855
• Device Sequence Number: 1
• Product Code: GEF
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73D1800210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1