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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
Model Number IPN010797
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73f1900228 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 the doctor noticed that during the intervention (radical prostatectomy), the applier stopped firing clips.Dysfunctional jaws.Consequence: another applier was used.There was no consequence for the patient.
 
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 rotation tab bent and its trigger partially engaged.The first clip was protruding from the channel.The returned sample appears used as there is biological material present on the device.First, the trigger cycle was completed.The first two clips were out of position in the channel.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 as it got stuck in the rotation tab.The clip was manually removed before completing the trigger cycle.Upon completing the trigger cycle, the next clip also fired incorrectly.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.The sample was received with 6 clips remaining in the channel indicating that 9 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 "applier jammed" was confirmed based upon the sample received.The device was returned with its rotation tab bent.The sample was returned with 6 clips remaining indicating that 9 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.
 
Event Description
It was reported that the doctor noticed that during the intervention (radical prostatectomy), the applier stopped firing clips.Dysfunctional jaws.Consequence: another applier was used.There was no consequence for the patient.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9936028
MDR Text Key187027688
Report Number3003898360-2020-00327
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 03/18/2020
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 Date06/10/2022
Device Model NumberIPN010797
Device Catalogue NumberAE05ML
Device Lot Number73F1900228
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2020
Initial Date Manufacturer Received 03/18/2020
Initial Date FDA Received04/08/2020
Supplement Dates Manufacturer Received04/29/2020
Supplement Dates FDA Received05/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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