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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON APPLIER ETHICON ENDO 5MM CLIP

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JOHNSON AND JOHNSON APPLIER ETHICON ENDO 5MM CLIP Back to Search Results
Model Number 253402
Device Problem Failure to Fire (2610)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/05/2016
Event Type  Injury  
Event Description

Ethicon 5mm clip applier did not load or fire properly. Neurosurgeon was attempting to clip a vessel when the clip applier did not fire. Another 5mm clip applier was immediately opened and the bleeder was controlled.

 
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Brand NameAPPLIER ETHICON ENDO 5MM CLIP
Type of DeviceAPPLIER ETHICON ENDO 5MM CLIP
Manufacturer (Section D)
JOHNSON AND JOHNSON
1 johnson and johnson plaza
new brunswick NJ 08933
MDR Report Key6202185
MDR Text Key63304678
Report NumberMW5066891
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number253402
Device Catalogue NumberEL5ML
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/22/2016 Patient Sequence Number: 1
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