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 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device history review for the product auto endo5 ml lot #73l1800544 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 clips were getting stuck in the applicator.

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 a clip with a broken hook partially loaded incorrectly.The 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 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.A double feed occurred on the first attempt, where the second clip was right behind the first clip and was protruding from the channel.Resistance was also felt upon engaging the trigger.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.The proximal end of the feeder was slightly bent due to the clip stacking.The sample was received with 11 clips remaining including the partially loaded clips, indicating that 4 clips were fired by the end user.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 stuck in applier" was confirmed based upon the sample received.One device was returned with a clip with a broken hook partially loaded incorrectly.Upon functional inspection, a double feed occurred on the first attempt.Resistance was also felt upon engaging the trigger.The sample was disassembled , and it was found that the clips were out of position and stacking on one another.The proximal end of the feeder was slightly bent due to the clip stacking.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 became out of position.A capa has been opened to further investigate this issue.

Event Description

It was reported that clips were getting stuck in the applicator.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8713630
• MDR Text Key: 148541647
• Report Number: 3003898360-2019-00701
• 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: 05/29/2019

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: 11/18/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73L1800544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1