BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 4093266 · Received September 16, 2014

    Report

    Report Number
    2955842-2014-05368
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 6, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. VISUAL INSPECTION FOUND, INSTRUMENT CLEVIS PIN WAS BROKEN. THE PIN WHICH CONTAINS THE CLEVIS HUB WAS BROKEN OFF AND MISSING. THE PULLEY CAN MOVE OUTSIDE THE CLEVIS WHEN IN MOTION. THERE WAS NO PHYSICAL DAMAGE TO THE CLEVIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE MISSING CLEVIS PIN IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING STERILIZATION PROCESS, SOME PLASTIC COMPONENT HAD FALLEN OUT ON THE PERMANENT CAUTERY HOOK INSTRUMENT. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571593 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-06 M10131122 931

    Patients

    Seq Age Sex Outcome Treatment
    1