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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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73e1900527 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 laparoscopic distal gastrectomy, he/she tried to ligate the tissue but some clips were not loaded into the jaws properly.No clips fell or remained in the patient's body, and no health injury is reported so far.
 
Event Description
It was reported that during laparoscopic distal gastrectomy, he/she tried to ligate the tissue but some clips were not loaded into the jaws properly.No clips fell or remained in the patient's body, and no health injury is reported so far.
 
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 jaws partially closed.A broken clip was stuck in the bent rotation tab.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.No clip loaded initially , and resistance was felt during the trigger pull.A closed clip fired at the end of the trigger cycle.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.Both jaws were bent slightly and the pivot holes in the channel were damaged.The clip stacking prevented the clips from properly loading into the jaws.The sample was received with 10 clips remaining in the channel, indicating that 5 clips were fired by the end user.A capa has been opened to further investigate the clip stacking issue.The sample was received with 10 clips remaining in the channel, indicating that 5 clips were fired by the end user.A capa has been opened to further investigate the clip stacking 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(s) not loading properly" was confirmed based upon the sample received.One device was returned with 10 clips remaining, indicating that 5 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.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
morrisville NC
MDR Report Key10086710
MDR Text Key191976605
Report Number3003898360-2020-00442
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 foreign,health professional
Type of Report Initial,Followup
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/20/2022
Device Catalogue NumberAE05ML
Device Lot Number73E1900527
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Date Manufacturer Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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