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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO MED/LG APPLIER
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ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO MED/LG APPLIER Back to Search Results
Catalog Number EL314
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: was there any patient consequence? no.Did clips fall off of vessel after applied? clips fall of when physician removed the clip applier.Were clips that were applied to vessel malformed? vessel wasn`t malformed.How was the procedure completed? physician used another one device the same type.According to physician they using clips from other manufacturer not j&j company.
 
Event Description
The clip applier keep clips incorrectly.Moreover even if clips has been implemented often situation is when clips can be removed without any additional force from tissue.
 
Manufacturer Narrative
(b)(4).Device analysis: the analysis results found that the el314 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended.The instrument was fully functional and conforming to our manufacturing requirements.No conclusion could be reached as to what may have caused the reported incident.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment. .
 
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Type of Device
LIGACLIP
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key7303740
MDR Text Key101471338
Report Number3005075853-2018-08263
Device Sequence Number1
Product Code HBT
UDI-Device Identifier20705036003851
UDI-Public20705036003851
Combination Product (y/n)N
PMA/PMN Number
K830503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEL314
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Date Manufacturer Received03/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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