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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 Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73l1800545 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 cholecystectomy, when the vessels, artery and cystic duct were clamped, the applier did not work normally, the clips did not come out.Another applier from the same batch was used as a replacement, it worked correctly.There was a slight delay in the procedure but no patient consequences.
 
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 the first clip out of position and the rotation tab bent.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 unable to load properly into the jaws as the clip was located to the side of the pusher head (distal end of feeder).The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.The sample was received with 6 clips remaining in the channel indicating that 9 clips were fired by the end user.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.Non-conformance 60047180 has been opened to further investigate the clip stacking issue.The reported complaint of "clip stuck in applier" was confirmed based upon the sample received.One sample was returned with the rotation tab bent and the first clip out of position in the channel.The sample was received with 6 clips remaining in the channel indicating that 9 clips were fired by the end user.Upon functional inspection, the first clip was unable to load properly into the jaws as the clip was located to the side of the pusher head (distal end of feeder).It was found 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.
 
Event Description
It was reported that during a laparoscopic cholecystectomy, when the vessels, artery and cystic duct were clamped, the applier did not work normally, the clips did not come out.Another applier from the same batch was used as a replacement, it worked correctly.There was a slight delay in the procedure but no patient consequences.
 
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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 Key8709586
MDR Text Key148352354
Report Number3003898360-2019-00652
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 05/21/2019
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 Date11/18/2021
Device Catalogue NumberAE05ML
Device Lot Number73L1800545
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Initial Date Manufacturer Received 05/21/2019
Initial Date FDA Received06/18/2019
Supplement Dates Manufacturer Received07/10/2019
Supplement Dates FDA Received07/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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