BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 3971649 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04645
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 24, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT OF INSTRUMENT WAS PLUGGED IN AND DID NOT WORK. THERE WAS NO TROUBLE FOUND. THE INSTRUMENT WAS NOT PLACED ON AN IN-HOUSE DA VINCI SYSTEM DUE TO THE CONDITION OF THE GRIPS. THE KNIFE WAS IN THE GARAGE AND THE INSTRUMENT HAD NO BIO-DEBRIS. FAILURE ANALYSIS INVESTIGATION OBSERVED THE FOLLOWING: THE INSTRUMENT'S GRIP TIPS WERE BROKEN. THE GRIPS HAD PIECES THAT COMPLETELY BROKE OFF FROM THE TIPS AND A SMALL PIECE WAS RETURNED WITH THE INSTRUMENT WHICH MEASURED APPROXIMATELY 0.581; HOWEVER, IT WAS STILL MISSING A PLASTIC PIECE. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. IN ADDITION, THE INSTRUMENT'S SNAKE WRIST WAS DISLODGED WHICH CAN CAUSE THE INSTRUMENT TO BE NON-INTUITIVE. FAILURE ANALYSIS CONCLUDED THAT THE DISLODGED SNAKE WRIST MAY BE DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN GRIP TIPS WITH MISSING MATERIAL AND DISLODGED SNAKE WRIST FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, WHILE THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT WAS PLUGGED IN, IT WAS OBSERVED THAT IT DID NOT WORK. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. PER THE CUSTOMER, THE INSTRUMENT WOULD NOT TURN ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447716 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-05 S10140407 129

    Patients

    Seq Age Sex Outcome Treatment
    1