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

Model Number IPN010797

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73f1900481 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 clips fall out of the applier.

Event Description

It was reported that clips fall out of the applier.

Manufacturer Narrative

(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without mag nification.Visual examination of the returned device revealed that the sample was returned with blue adhesive residue on the handle.The sample appears used as there is biological material present on the device.Reference file (b)(4) for investigation photos.Dimensional inspection was performed on the jaw spring and the bottom jaw.A digital caliper (equipment id 10081388 and calibration due date nov.11, 2020) was used to take the measurements.The thickness of the jaw leg on the bottom jaw where the jaw spring connects was measured.The specification as outlined in part drawing g00455 is.010" +/-.001".The thickness was measured to be.0105" which meets the specification.Additionally, height of the jaw spring tips were measured.The specification as outlined in part drawing tfx-001524 is.0150" +.0025 "/-.0020".The height of the tip that connects to the bottom jaw was measured to be.0140".The height of the tip that connects to the top jaw was measured to be.0155".Both tips on the jaw spring were within the specification.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.The first clip fell out of the device since the bottom jaw was not closing properly.The jaw spring appears disengaged preventing the bottom jaw from closing properly.Another attempt was made with the same result.The sample was disassembled in order to inspect the internal components.It was found that the clips were out of position and stacking on one another in the channel.Dimensional inspection was performed on the bottom jaw and jaw spring.Both components were within specification.The sample was received with 6 clips remaining in the channel indicating that 9 clips were fired by the end user.The jaw spring being disengaged from the bottom jaw would prevent the bottom jaw from closing properly.If a clip misloads and is not manually cleared prior to loading another clip, the clips can be held up in the loading sequence and stack on one another in the channel.The root cause of this complaint issue was that the jaw spring disconnected from the bottom jaw.However, it could not be determined why or how this occurred.Reference file (b)(4) for investigation photos.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 part drawings for the bottom jaw, g00455, and jaw spring, tfx-001524, were also reviewed as a part of this complaint investigati on.A corrective action is not required at this time since the root cause of the complaint could not be determined.However, there is no evidence to suggest a manufacturing related cause since the affected components were found to be within specification.The reported complaint of "clips fall out of the applier" was confirmed based upon the sample received.Upon functional inspection, it was found that the jaw spring was disengaged from the bottom jaw which prevented the jaw from closing properly when the device is fired.Dimensional inspection was performed to on the bottom jaw and the jaw spring.All measurements taken were found to meet the specifications.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.It is unlikely that these types of damages were present at the time of manufacturing.A device history record review was performed on the device with no evidence to suggest a manufacturing related defect.The root cause of this complaint issue was that the jaw spring disconnected from the bottom jaw during use.However, it could not be determined why or how this occurred.We will continue to monitor and trend on this issue.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9664813
• MDR Text Key: 177958418
• Report Number: 3003898360-2020-00160
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: IPN010797
• Device Catalogue Number: AE05ML
• Device Lot Number: 73F1900481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1