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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Catalog Number AE05ML
Device Problems Activation, Positioning or Separation Problem (2906); Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml, lot# 73l1800543 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 during a laparoscopic sigmoidectomy, the fourth and after clips were not loaded properly so that they failed to ligate and fell.All of them were retrieved and the unit was replaced with a new unit to complete the surgery.
 
Event Description
It was reported that during a laparoscopic sigmoidectomy, the fourth and after clips were not loaded properly so that they failed to ligate and fell.All of them were retrieved and the unit was replaced with a new unit to complete the surgery.
 
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 its trigger partially engaged and its rotation tab bent.A clip was partially loaded incorrectly into the jaws of the applier as the clip was to the side of the pusher head (distal end of feeder).The indicator clip was in the next position in the channel.The sample appears used as there is biological material present on the device.First, the partially loaded clip was manually removed , and the trigger cycle was completed.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 indicator clip fired indicating that no clips were remaining in the device.The sample was disassembled to inspect the internal components.The proximal end of the feeder was found bent.The sample was received with only the partially loaded clip remaining indicating that 14 clips were fired by the end user.There were no clips remaining in the channel for testing.The bent rotation tab, the partially loaded clip being to the side of the pusher head and the proximal end of the feeder being bent are indications that the clips were out of position and stacking on one another.The clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A non-conformance has been opened to further investigate this issue.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 came out of position.A nonconformance has been opened to further investigate the clip stacking issue.The reported complaint of "clips not loaded properly" was confirmed based upon the sample received.One sample was returned with its trigger partially engaged and its rotation tab bent.A clip was partially loaded incorrectly into the jaws of the applier as the clip was to the side of the pusher head (distal end of feeder).The indicator clip was in the next position in the channel.Upon functional inspection, the indicator clip fired indicating that no clips were remaining in the device.Upon disassembly, the proximal end of the feeder was found bent.The sample was received with only the partially loaded clip remaining indicating that 14 clips were fired by the end user.There were no clips remaining in the channel for testing.The bent rotation tab, the partially loaded clip being to the side of the pusher head and the proximal end of the feeder being bent are indications that the clips were out of position and stacking on one another.The clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A non-conformance has been opened to further investigate this issue.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8591246
MDR Text Key144431178
Report Number3003898360-2019-00517
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K152081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/18/2021
Device Catalogue NumberAE05ML
Device Lot Number73L1800543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Date Manufacturer Received06/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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