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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL ENDOWRIST HOT SHEARS MONOPOLAR CURVED SCISSORS

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INTUITIVE SURGICAL ENDOWRIST HOT SHEARS MONOPOLAR CURVED SCISSORS Back to Search Results
Catalog Number 420179
Event Date 09/04/2012
Event Type  Malfunction  
Event Description

During the procedure, the surgeon noted the instrument was arcing unintentionally, and burned the uterus. The tip was changed out and it continued to arc. A new instrument was opened and functioned with no problems. It is unknown if the new instrument was of the same or a different lot. ======================manufacturer response for monopolar curved scissors, da vinci monopolar curved scissors (per site reporter). ======================they want the device back within a very short period of time or they reserve the right to cancel the rma without notice.

 
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Brand NameENDOWRIST HOT SHEARS
Type of DeviceMONOPOLAR CURVED SCISSORS
Manufacturer (Section D)
INTUITIVE SURGICAL
950 kifer road
sunnyvale CA 94086
MDR Report Key2842683
Report Number2842683
Device Sequence Number1
Product CodeNAY
Report Source User Facility
Type of Report Initial
Report Date 10/10/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number420179
Device LOT NumberM10120711 637
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/10/2012
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2012
Event Location Hospital

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