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

Catalog Number AE05ML

Device Problems Activation, Positioning or Separation Problem (2906); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73m1800229 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 clip failed to load and spilled.

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 double feed and its rotation tab bent.The last clip and the indicator clip were both partially loaded incorrectly.The jaw spring was disengaged from the jaws.The jaw spring was also bent and was protruding from the tube slots.The sample appears used as there is biological material present on the device.Reference file (b)(4) for investigation photos.Functional inspection could not be performed due to the condition of the returned sample.However, the sample was disassembled to inspect the internal components.Upon disassembly, it was found that the proximal end of the feeder was bent.The sample was received with 1 clip remaining in the channel indicating that 14 clips were fired by the end user.The bent rotation tab, double feed, and bent feeder are all indications that the clips were out of position and stacking on one another in the channel.The clip stacking could prevent the clips from properly loading into the jaws.The clip stacking also caused the damage to the jaw spring.A capa has been opened to further investigate this issue.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 reported complaint of "clip failed to load and spilled" was confirmed based upon the sample received.One device was returned.The sample was returned with a double feed and its rotation tab bent.The jaw spring was disengaged from the jaws.The jaw spring was also bent and was protruding from the tube slots.The device was received with 1 clip remaining in the channel indicating that 14 clips were fired by the end user.The device was disassembled , and it was found that the proximal end of the feeder was bent.The bent rotation tab, double feed, and bent feeder are all indications that the clips were out of position and stacking on one another in the channel.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.

Event Description

It was reported that the clip failed to load and spilled.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9317983
• MDR Text Key: 170068228
• Report Number: 3003898360-2019-01312
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73M1800229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1