• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Catalog Number AE05ML
Device Problem Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2020
Event Type  malfunction  
Manufacturer Narrative
(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 the rotation tab bent and the tip of the rotation tab broken off.The sample appears used as there is biological material present on the device.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 was able to load properly and was successfully applied to over-stressed surgical tubing.The indicator clip was in the next position of the channel indicating that no clips were remaining.The indicator clip was fired.The sample was disassembled to inspect the internal components.No further damages were observed.The sample was received with 1 clip remaining in the channel, indicating that 14 clips were fired by the end user.Although the lone clip remaining fired properly, the bent rotation tab is an indication that the clips were out of position and stacking on one another in the channel.The clip stacking could prevent the clips from loading properly into the jaws.It could not be determined exactly how or when the clips became out of position.Capa has been opened to further investigate this issue.Other remarks: the device history review for the product auto endo5 ml lot# 73d1900709 was manufactured on 04/30/2019 a total of (b)(4) pieces.Lot was released on 05/08/2019.Dhr investigation did not show issues related to the complaint.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 could prevent the clips from loading properly into the jaws.It could not be determined exactly how or when the clips became out of position.The reported complaint of unit misfired was confirmed based upon the sample received.One sample was returned with the rotation tab bent and the tip of the rotation tab broken off.Upon functional inspection, the lone clip fired properly.However, the bent rotation tab is an indication that the clips were out of position and stacking on one another.The clip stacking could prevent 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.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during use the auto endo misfired causing the clips to break.No clips fell into the patient.The device was removed from the patient, cleaned and tested outside of the patient.It continued to misfire.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9936124
MDR Text Key187026235
Report Number3003898360-2020-00329
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/29/2022
Device Catalogue NumberAE05ML
Device Lot Number73D1900709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/20/2020
Initial Date FDA Received04/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-