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

Catalog Number AE05ML

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml, lot# 73e1800325 investigation did not show issues related to the complaint.The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

The clip slipped or fell during loading.

Event Description

The clip slipped or fell during loading.

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 the jaws partially closed and no clip in the first position of the channel.It appears that the top jaw is disengaged from the jaw spring.The sample appears used as there is biological material present on the device.Functional inspection was 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.No clip fired.Several attempts were made with the same result.The sample was disassembled to inspect the internal components.It was observed that the jaw spring was bent, which caused it to disengage from the top jaw.One of the pivot holes in the channel for the top jaw was also slightly deformed.The yoke was broken at the pin position but this could have occurred during disassembly.The sample was received with 0 clips remaining in the channel indicating that 15 clips were fired by the end user.The damage to the jaw spring caused the top jaw to disengage and prevented the clips from loading properly into the jaws of the device.R & d was consulted and since the sample was returned with no clips remaining, it could not be determined how or when the jaw spring got bent.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." a corrective action is not required at this time as it could not be determined what caused the jaw spring to bend, since no clips were remaining in the returned sample.The device history record review showed no evidence to suggest a manufacturing related cause.The reported complaint of "the clip is not loaded and is locked out" was confirmed based upon the sample received.One sample was returned with the jaws partially closed and no clip in the first position of the channel.It appeared as though the top jaw was disengaged from the jaw spring.Upon functional inspection, no clip fired.The sample was received with 0 clips remaining in the channel indicating that 15 clips were fired by the end user.The sample was disassembled to inspect the internal components.It was observed that the jaw spring was bent, which caused it to disengage from the top jaw.One of the pivot holes in the channel for the top jaw was also slightly deformed.The damage to the jaw spring caused the top jaw to disengage and prevented the clips from loading properly into the jaws of the device.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.A device history record review was performed on the autoend05 with no evidence to suggest a manufacturing related cause.R & d was consulted and since the sample was returned with no clips remaining, it could not be determined how or when the jaw spring got bent.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8591681
• MDR Text Key: 144443301
• Report Number: 3003898360-2019-00523
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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: 05/06/2019
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1