BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2881900 · Received December 20, 2012

    Report

    Report Number
    2955842-2012-01381
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    August 21, 2012
    Report Date
    September 6, 2012
    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. ENGINEERING FOUND TUBE DAMAGE NOT REPORTED BY SITE. DISTAL END OF THE MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE .050 - .200 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. THE EVIDENCE IS NOT CONCLUSIVE, BUT DAMAGE MAY HAVE BEEN CAUSED BY MISHANDLING/MISUSE. THE CUSTOMER 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. THE CLEANING AND STERILIZATION USER MANUAL SPECIFICALLY STATES: O WHEN SCRUBBING THE TIP OF CAUTERY INSTRUMENTS, TAKE CARE NOT TO DAMAGE THE INSULATION. O DO NOT EXPOSE INSTRUMENTS TO HYDROGEN PEROXIDE (H2O2), BLEACH...

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A PROBLEM. 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 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10120202 990

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES