BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 2940423 · Received February 3, 2013

    Report

    Report Number
    2955842-2013-00343
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF INSTRUMENT TIP WAS BURNED WAS CONFIRMED. INSTRUMENT WAS FOUND WITH CHARRED MARK ON THE PROXIMAL CLEVIS NEAR THE MAIN TUBE CONNECTION. THERE WAS A HAIRLINE CRACK FOUND ON THE CLEVIS NEAR THE CHAR MARKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF REPORTED SEEING A BURNED TIP ON THE PERMANENT CAUTERY HOOK INSTRUMENT NOTHING WAS REPORTED HAVING FALLEN INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45732 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-05 M10110215 627

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, & ES