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

Model Number IPN010797

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73g1900093 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 applier delivered 2 clips.The 3rd clip got stuck in the jaws.So, it was impossible to use the applier anymore.There was no consequence for the patient.

Event Description

It was reported that the applier delivered 2 clips.The 3rd clip got stuck in the jaws.So, it was impossible to use the applier anymore.There was no consequence for 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 rotation tab was severely bent.There was also a clip improperly loaded into the jaws.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Once the improperly loaded clip was removed, the trigger was engaged , and an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The first clip was unable to properly load and it fell from 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 properly loading into the jaws.The sample was received with 12 total clips remaining in the channel indicating that 3 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.".Although the root cause of this complaint issue could not be determined, a capa has been opened to further investigate the clip stacking issue.The reported complaint of "clip(s) not loading properly" was confirmed based upon the sample received.The sample was returned with its rotation tab severely bent.Upon functional inspection, the clips were unable to properly load into the jaws of the applier.Upon disassembly, 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 capa has been opened to further investigate this issue.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11364747
• MDR Text Key: 233048160
• Report Number: 3003898360-2021-00179
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 14026704553126
• UDI-Public: 14026704553126
• Combination Product (y/n): N
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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: 07/01/2022
• Device Model Number: IPN010797
• Device Catalogue Number: AE05ML
• Device Lot Number: 73G1900093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1