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

Catalog Number AE05ML

Device Problems Break (1069); Material Twisted/Bent (2981); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml, lot #73g1800172.Investigation did not show issues related to complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the clip jammed, and the jaw was broken.The clip was bitten when loaded and was not loaded, jaw was bent so clip was out of it.

Event Description

It was reported that the clip jammed, and the jaw was broken.The clip was bitten when loaded and was not loaded, jaw was bent so clip was out of it.

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 trigger partially engaged and the rotation tab bent.A closed clip was partially loaded incorrectly , and another clip was stuck in the bent rotation tab.The sample appears used as there is biological material present on the device.First, the clips were manually removed , and the trigger cycle was completed.It was observed that the next clip was out of position in the channel.Functional inspection was then 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 next clip was unable to load properly into the jaws as the pusher head (distal end of feeder) was to the side of the clip.The sample was disassembled to inspect the internal components.No further damages were found.The sample was received with 4 clips remaining including partially loaded clips, indicating that 11 clips were fired by the end user.The bent rotation tab, clip misfire and clips being out of position are indications that the clips were out of position and stacking on one another in the channel.The clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.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 reported complaint of "clip jam" was confirmed based upon the sample received.One sample was returned with the rotation tab bent.A closed clip was partially loaded incorrectly , and another clip was stuck in the bent rotation tab.Upon functional inspection, the first clip was unable to load properly as the pusher head (distal end of feeder) was to the side of the clip.The bent rotation tab, clip misfire and clips being out of position are all indications that the clips were out of position and stacking on one another in the channel.The clip stacking prevented the clips from loading properly into the jaws.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips came 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; research triangle park NC
• MDR Report Key: 8816188
• MDR Text Key: 151866000
• Report Number: 3003898360-2019-00907
• 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: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73G1800172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1