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 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The 1st clip was not loaded into the jaws properly during an operation.The 2nd clips and after were loaded in closed condition.Therefore, the user stopped using the device.

Event Description

The 1st clip was not loaded into the jaws properly during an operation.The 2nd clips and after were loaded in closed condition.Therefore, the user stopped using the device.

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 rotation tab bent.No clip was in the first position in the channel.The sample appeared 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 on the first attempt, but the next clip loaded into the correct position in the channel.On the next attempt, the next clip was unable to properly load 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 properly loading into the jaws and cause the rotation tab to get damaged/bent.Additionally, a tab on the channel box was found to be bent.The sample was received with 4 clips remaining, indicating that 11 clips were fired by the end user.A capa has been opened to further investigate this issue.Multiple root causes have been identified for clip stacking issues, centered around design and manufacturing related root causes.Additionally, user error can contribute to clip stacking issues.Corrective actions are being implemented via the capa.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 capa has been opened to further investigate this issue.Multiple root causes have been identified for clip stacking issues, centered around design and manufacturing related root causes.Additionally, user error can contribute to clip stacking issues.Corrective actions are being implemented via the capa.The reported complaint of "clip(s) not loading properly" was confirmed based upon the sample received.The device was returned with its rotation tab and another tab on the channel box bent.The sample was returned with 4 clips remaining, indicating that 11 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.A capa has been opened to further investigate this issue.Multiple root causes have been identified for clip stacking issues, centered around design and manufacturing related root causes.Additionally, user error can contribute to clip stacking issues.Corrective actions are being implemented via the capa.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11854991
• MDR Text Key: 251680468
• Report Number: 3003898360-2021-00506
• 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: 05/17/2021

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: 06/04/2022
• Device Model Number: IPN010797
• Device Catalogue Number: AE05ML
• Device Lot Number: 73F1900184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1