BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3924439 · Received July 9, 2014

    Report

    Report Number
    2955842-2014-04196
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    March 16, 2014
    Report Date
    June 9, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE YAW PULLEY EXHIBITED THERMAL DAMAGE. ELECTRICAL CONTINUITY TESTING WAS PERFORMED AND PASSED. NO OTHER DAMAGE WAS FOUND. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THERMAL DAMAGE WAS FOUND ON THE PERMANENT CAUTERY SPATULA INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS INSTALLED ON THE DA VINCI SYSTEM PATIENT SIDE MANIPULATOR (PSM) ARM 1. THE INSTRUMENT STARTED SMOKING AFTER SEVERAL MINUTES OF USE. THE INSTRUMENT WAS REMOVED AND REPLACED, AND DEFECTIVE INSTRUMENT WAS SENT TO THE BIOMED. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE USER FACILITY AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HE INDICATED THAT THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS INSPECTED PRIOR TO THE SURGICAL PROCEDURE AND NO ISSUES WERE OBSERVED. THE SURGICAL STAFF INDICATED THAT THE INSTRUMENT STARTED SMOKING DURING THE SURGICAL PROCEDURE. NO ARCING WAS OBSERVED. AFTER THE SMOKE WAS OBSERVED, THE SURGICAL STAFF REMOVED AND REPLACED THE PERMANENT CAUTERY SPATULA INSTRUMENT WITH ANOTHER INSTRUMENT AND THE SURGICAL PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES REPORTED. HE DENIED THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS AND WAS NOT AWARE OF THE PATIENT RETURNING FOR ANY POST-OPERATIVE COMPLICATIONS. HE DID NOT KNOW IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401602 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10120529 476

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR