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

Catalog Number AE05ML

Device Problem Failure to Advance (2524)

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 #73g1800294 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 the clips were stuck in the applier.The unit was replaced with a new one to complete the operation.No clip fell in the patient.

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 clip was partially loaded incorrectly into the jaws of the applier.The returned sample appears used as there is biological material present on the device.First, the partially loaded clip was manually removed , and the trigger cycle was completed.It was observed that there was no clip in the next position of the channel.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 stuck in applier" was confirmed based upon the sample received.One device was returned with the rotation tab bent and a clip partially loaded incorrectly into the jaws of the applier.No clip fired on the first attempt.The indicator clip was in the next position of the channel indicating that there were no clips remaining in the channel.The indicator clip was fired , and the sample was disassembled to inspect the internal components.The proximal end of the feeder was bent.The sample was received with 0 clips remaining in the channel indicating that all 15 clips were fired by the end user.The bent rotation tab and the proximal end of the feeder being bent are indications that the clips were out of position and stacking on one another in the channel.The clip stacking could prevent 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.

Event Description

It was reported that the clips were stuck in the applier.The unit was replaced with a new one to complete the operation.No clip fell in the patient.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8708063
• MDR Text Key: 148304747
• Report Number: 3003898360-2019-00706
• 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: 05/24/2019

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: 07/10/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73G1800294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1