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

Catalog Number AE05ML

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during a cholecystectomy the first 2-3 clips were fired without issue, then the clip was not loaded or fell.

Event Description

It was reported that during a cholecystectomy the first 2~3 clips were fired without issue, then the clip was not loaded or fell.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73l1700351 was manufactured on 11/20/2017 a total of 285 pieces.Lot was released on 11/24/2017.Dhr investigation did not show issues related to complaint.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 with a bent rotation tab.A double feed was observed on the returned sample as there was a clip partially loaded incorrectly in the jaws and another clip stuck in the bent rotation tab.The returned sample appears used as there is biological material present on the device.First, the two clips from the double feed were manually removed and the trigger cycle was completed.At this time, 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 of the device.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from loading properly into the jaws of the device.The sample was received with 11 clips remaining in the channel including the double feed that occurred, indicating that 4 clips were fired by the end user.A 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 "clip loading and slippage issue" was confirmed based upon the sample received.One device was returned with 11 clips remaining including the double feed, indicating that 4 clips were fired by the end user.Upon functional inspection, it was found that the clips were out of position and stacking on one another which prevented the clips from loading properly into the jaws of the device.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 non-conformance 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: 8244420
• MDR Text Key: 132961513
• Report Number: 3003898360-2019-00014
• 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: 12/20/2018

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: 05/14/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1800325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 02/01/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1