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

Catalog Number AE05ML

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product auto endo5 ml lot# 73g1900661 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 doctor was doing a laparoscopy cholecystectomy.Fired first clip and handle did not open all the way.Took it out and fired another one outside and worked fine.Fired 4 more clips successfully.Doctor was loading and using device correctly.On 6th clip no clip loaded.Asked doctor to take device out and cycle 2.Each one came out closed.Device was unrecoverable.Doctor was also going down a 11mm trocar so no issues on going through the trocar.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 9706550
• MDR Text Key: 179416919
• Report Number: 3003898360-2020-00194
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2022
• Device Catalogue Number: AE05ML
• Device Lot Number: 73G1900661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1