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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 543965
Device Problem Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73f1800760 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 prior to application to the patient, the customer shot one clip, but clips fell from the vessel.A 2nd box was opened, but the same issue was found.The 3rd one was fine and treatment was completed.
 
Event Description
It was reported that prior to application to the patient, the customer shot one clip, but clips fell from the vessel.A 2nd box was opened, but the same issue was found.The 3rd one was fine and treatment was completed.
 
Manufacturer Narrative
Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73f1800760 was manufactured on 06/28/2018 a total of 288 pieces.Lot was released on 07/02/2018.Dhr investigation did not show issues related to complaint.The customer returned one unit of 543965 autoendo5 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that 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 was heard indicating that the internal ratchet ears are intact.The first clip was unable to properly load into the jaws as it was unable to latch onto the bottom jaw.Upon further examination, it was observed that there was a buildup of biological material in the bottom jaw which prevented the clip from loading properly.The buildup of biological material was manually removed , and another attempt was made to fire the device.This time, a clip was able to properly load into the jaws of the applier and was successfully applied to over-stressed surgical tubing.This was repeated with the same result for the remaining clips.The sample was received with 5 clips remaining in the channel indicating that 10 clips were fired by the end user.The root cause of this complaint issue is the buildup of biological material in the bottom jaw.There were no functional issues found with the device itself.Therefore, based on the condition of the returned sample, operational context caused or contributed to this event.The reported complaint of "clip fell" was confirmed based upon the sample received.Upon functional inspection, it was found that a buildup of biological material was stuck in the bottom jaw which prevented the first clip tested from properly loading.Once the buildup was removed, the remaining clips were able to fire properly.There were no functional issues found with the device.Since the first clip was unable to load due to the buildup of biological material in the jaw, operational context caused or contributed to this event.
 
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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 Key8244001
MDR Text Key132933598
Report Number3003898360-2019-00010
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K021808
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/21/2018
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 Date06/27/2021
Device Catalogue Number543965
Device Lot Number73F1800760
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2019
Initial Date Manufacturer Received 12/21/2018
Initial Date FDA Received01/14/2019
Supplement Dates Manufacturer Received02/05/2019
Supplement Dates FDA Received02/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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