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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML
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TELEFLEX MEDICAL AUTO ENDO5 ML Back to Search Results
Catalog Number AE05ML
Device Problems Bent (1059); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73b1800292 investigation did not show issues related to the complaint.The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that after five successful firings, the device would not fire.Clips would not load in the jaws.When he took the device out it appeared that the jaws end effector looked crooked and damaged.There was no patient injury.
 
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 a clip seated too far forward in the channel and jammed up against the bottom jaw which made the bottom jaw get stuck out of position.The rotation tab was bent.The returned sample appears used as there is biological material present on the device.(b)(4).This sample was reviewed with a r & d engineer.The first clip was manually removed and it was found that the clip was broken in half.Only one half of the clip was removed.The other half was not in 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 clip was unable to properly load into the jaws.On the next attempt, a double feed occurred.The double feed, bent rotation tab, and broken clip are all indications that the clips were out of position in the jaws.The sample was disassembled to inspect the internal components.Upon disassembly, it was found other remarks: that the distal end of the channel was bent as a result of the clip that was stuck in the jaw.The remaining clips in the channel were in the correct position.No damages were observed to the bottom jaw or the outer tube.It appears that the load aperture of the bottom jaw was low during loading of the clip which resulted in the clip getting stuck against the jaw.This caused a small logjam of clips in the channel that contributed to the distal end of the channel and the rotation tab getting bent.It also caused a clip to break and a double feed.An external force being applied to the bottom jaw during loading could cause it to have low load aperture, but it could not be determined what caused the low load aperture.The sample was received with 8.5 clips remaining in the channel indicating that 6 clips were fired by the end user and the other half of the broken clip fell out of the device.Although it was confirmed that the bottom jaw had low load aperture, it could not be determined what caused this to occur.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." a corrective action is not required at this time as it could not be determined what caused the complaint issue.It appears that the complaint issue was caused by low load aperture of the bottom jaw but it could not be determined why this occurred.The reported complaint of "loading issues" was confirmed based upon the sample received.One device was returned.The sample was returned with a clip seated too far forward in the channel and jammed up against the bottom jaw which made the bottom jaw get stuck out of position.The rotation tab was bent.The first clip was manually removed and it was found that the clip was broken in half.It appears that the load aperture of the bottom jaw was low during loading of the clip which resulted in the clip getting stuck against the jaw.This caused a small logjam of clips in the channel that contributed to the distal end of the channel and the rotation tab getting bent.It also caused a clip to break and a double feed.No damages were observed to the bottom jaw or the outer tube.An external force being applied to the bottom jaw during loading could cause it to have low load aperture, but it could not be determined what caused the low load aperture.A device history record review was performed on the autoendo5 with no evidence to suggest a manufacturing related cause.The sample was received with 8.5 clips remaining in the channel indicating that 6 clips were fired by the end user and the other half of the broken clip fell out of the device.Although it was confirmed that the bottom jaw had low load aperture, it could not be determined what caused this to occur.Therefore, the root cause of this complaint is undetermined.
 
Event Description
It was reported that after five successful firings, the device would not fire.Clips would not load in the jaws.When he took the device out it appeared that the jaws end effector looked crooked and damaged.There was no patient injury.
 
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Brand Name
AUTO ENDO5 ML
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key7591585
MDR Text Key111232564
Report Number3003898360-2018-00402
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/11/2021
Device Catalogue NumberAE05ML
Device Lot Number73B1800292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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