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

Catalog Number AE05ML

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73j1800034 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 there was a jaw problem.The jaw is bent.

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 a feeder tab severely bent and protruding from the outer tube.Additionally, the rotation tab was bent , and no clip was in the first position in the channel.The returned sample appears used as there is biological material present on the device.Functional inspection could not be performed due to the feeder tab protruding from the tube.However, 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 properly loading into the jaws.The first feeder tab (from the distal end) was severely bent due to the clip stacking.Neither of the jaws were bent as was reported.The sample was received with 6 clips remaining in the channel indicating that 9 clips were fired by the end user.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 "jaw bent" was not confirmed based upon the sample received.The jaws of the returned device were not bent.However, a confirmed defect was found with the returned device.The sample was returned with a feeder tab severely bent and protruding from the tube.Additionally, its rotation tab was bent.Functional inspection could not be performed due to the feeder tab protruding from the channel.Upon disassembly of the device, 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 could not be confirmed, it was confirmed that the device had a defect.However, 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 there was a jaw problem.The jaw is bent.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8816632
• MDR Text Key: 151880426
• Report Number: 3003898360-2019-00917
• 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: 09/03/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73J1800034
• 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