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

Catalog Number AE05ML

Device Problems Leak/Splash (1354); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot #73e1900681 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 overlaid during surgery do not develop as are result of biting.

Event Description

It was reported that clips overlaid during surgery do not develop as are result of biting.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73e1900681 was manufactured on 05/27/2019 a total of (b)(4) pieces.Lot was released on 06/03/2019.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 appears used as there is biological material present on the device.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 not opened" was confirmed based upon the sample received.One sample was returned.Upon functional inspection, the first two clips fired properly.However, on the third attempt, no clip loaded but a clip shot out of the channel after the trigger cycle was completed.The next clip was out of position in the channel.The sample was disassembled and it was found that the clips were out of position and stacking on one another.A broken clip was found in the channel.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: 9622435
• MDR Text Key: 176965716
• Report Number: 3003898360-2020-00121
• 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
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73E1900681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1