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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTO ENDO5 ML; CLIP, IMPLANTABLE
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AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Catalog Number AE05ML
Device Problems Leak/Splash (1354); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73c1900442 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 an operation a clip was loaded misaligned and the tip of the jaws did not open.Therefore, the user stopped using the device and replaced it with a new one.No clip fell/remained in the patient.
 
Manufacturer Narrative
Qn# (b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.3003898360-2019-01152 is being reported as a malfunction.There was no serious injury.
 
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 trigger partially engaged and a clip partially loaded incorrectly.A loose clip was also returned.A tab on the distal end of the channel was bent inward.The sample appeared used as there is biological material on the device.First, the partially loaded clip was removed and the trigger cycle was completed.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 clip was unable to properly load into the jaws due to the bent tab on the distal end of the channel.The damaged tab is on the side of the bottom jaw.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that the bottom jaw was bent.The clips were found to be slightly out of position in the channel.The sample was received with 9 clips remaining, including the partially loaded clip, indicating that 6 clips were fired by the end user, including the loose clip that was returned.The tab on the distal end of the channel was bent inward which prevented the clips from loading properly and could also cause the clips to get out of position in the channel.The damage to the channel tab and the bottom jaw appeared to have occurred during use.Therefore, unintentional user error caused or contributed to this event.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." a corrective action is not required at this time as the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "clip loaded misaligned" was confirmed based upon the sample received.One device was returned with a tab on the distal end of the channel bent inward.The tab was on the side of the bottom jaw which was also bent.The sample was received with 9 clips remaining, including the partially loaded clip, indicating that 6 clips were fired by the end user, including the loose clip that was returned.The bent tab on the channel prevented the clips from loading properly and could also cause the clips to get out of position in the channel.A device history record review was performed on the autoend05 with no evidence to suggest a manufacturing related cause.The damage to the channel tab and the bottom jaw appeared to have occurred during use.Therefore, unintentional user error caused or contributed to this event.
 
Event Description
It was reported that during an operation a clip was loaded misaligned and the tip of the jaws did not open.Therefore, the user stopped using the device and replaced it with a new one.No clip fell/remained in the patient.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
MDR Report Key9161308
MDR Text Key161373459
Report Number3003898360-2019-01152
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,u
Type of Report Initial,Followup,Followup
Report Date 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/18/2022
Device Catalogue NumberAE05ML
Device Lot Number73C1900442
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Date Manufacturer Received10/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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