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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 Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml, lot #73l1800541.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 during laparoscopic nephrectomy, after several loading and ligation, a clip got stuck in the applier and did not come out to be loaded.The device was replaced with a new one.No clip fell/remained in the patient.
 
Event Description
It was reported that during laparoscopic nephrectomy, after several loading and ligation, a clip got stuck in the applier and did not come out to be loaded.The device was replaced with a new one.No clip fell/remained in the patient.
 
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 its rotation tab bent.The returned 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 properly load since the feeder was to the side of the clip.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.Additionally, the proximal end of the feeder was bent.The sample was received with 7 clips remaining in the channel indicating that 8 clips were fired by the end user.A capa 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 reported complaint of "clip stuck in applier" was confirmed based upon the sample received.The device was returned with its rotation tab bent.The sample was returned with 7 clips remaining in the channel indicating that 8 clips were fired by the end user.Upon functional inspection, it was found that the clips were out of position and stacking on one another which prevented the clips from loading properly into the jaws of the device.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.A capa 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 Key8793534
MDR Text Key151129109
Report Number3003898360-2019-00838
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 06/26/2019
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 Number73L1800541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Initial Date Manufacturer Received 06/26/2019
Initial Date FDA Received07/16/2019
Supplement Dates Manufacturer Received08/14/2019
Supplement Dates FDA Received08/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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