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

Catalog Number AE05ML

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the first clip failed to load properly.

Event Description

It was reported that the first clip failed to load properly.

Manufacturer Narrative

(b)(4).Per dhr the product auto endo5 ml lot # 73m1800266 was manufactured on (b)(6) 2018 a total of 288 pieces.Lot was released on (b)(6) 2018.Dhr investigation did not show issues related to complaint.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 its trigger partially engaged and with the rotation tab bent.A clip was stuck in the bent rotation tab.A closed clip was returned loose.The sample appears used as there is biological material present on the device.Reference file anp1900074696 for investigation photos.First, the clip stuck in the bent rotation tab was manually removed.Upon removal of the clip, the next clip protruded from the channel.The next clip was also removed and the trigger cycle was completed.The following clip was out of position in the channel.Functional inspection was then 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 following clip was unable to load properly into the jaws.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another in the channel.The sample was received with 8 clips remaining including the clip that was stuck in the bent rotation tab, indicating that 7 clips including the loose closed clip were fired by the end user.The clip stacking prevented the clips from loading properly into the jaws.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.Reference file anp1900074696 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 clip stacking prevented the clips from loading properly into the jaws.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.The reported complaint of "clips not loading properly" was confirmed based upon the sample received.One device was returned with the rotation tab bent.A clip was stuck in the bent rotation tab.A closed clip was also returned loose.Upon functional inspection, the clips were unable to load properly.The sample was disassembled and it was found that the clips were out of position and stacking on one another.The clip stacking prevented the clips from loading properly into the jaws.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: 9571096
• MDR Text Key: 175839041
• Report Number: 3003898360-2020-00115
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AE05ML
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1