BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 2883747 · Received December 21, 2012

    Report

    Report Number
    2955842-2012-01403
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 28, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED A BROKEN CONDUCTOR WIRE, YAW PULLEY CHARRING AND A MISSING FLUSH TUBE, NOT REPORTED BY SITE. THE CONDUCTOR WIRE IS BROKEN AT THE DISTAL END. THE BROKEN WIRE SEGMENT STICKS OUT AT THE WRIST. THE WIRE BROKE NEAR WHERE IT ENTERS THE YAW PULLEY. THE ELECTRICAL CONTINUITY FAILED. THE SIDE OF THE YAW PULLEY AND THE CONDUCTOR CAP EXHIBIT CHARRING AND LOCALIZED MELTING. THE WIRE DAMAGE LIKELY CREATED A PATH FOR ARCING. THE HOUSING WAS REMOVED TO FIND THE FLUSH TUBE MISSING FROM LUER PLATE. THE TUBE WAS LIKELY PULLED OUT DURING CLEANING PROCESS. ENGINEERING CONCLUDED THE FLUSH TUBE ISSUE IS LIKELY DUE TO IMPROPER CLEANING. THE REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERMANENT CAUTERY HOOK INSTRUMENT HAD A BROKEN WIRE. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-06 M10120113 983

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURGICAL SYSTEM AND ACCESSORIES