BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2991723 · Received March 6, 2013

    Report

    Report Number
    2955842-2013-00754
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED.  PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE INSTRUMENTS TIPS DID NOT ALIGN. ONE GRIP WAS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A .04 OFFSET AT THE TIPS. THE BENT GRIP HAD SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE LIKELY DUE TO MISHANDLING. AN ELECTRICAL CONTINUITY TEST PASSED. ADDITIONAL OBSERVATION FOUND A PITCH CABLE FRAYED AT THE DISTAL CELVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. THE FRAYED SEGMENT IS APPROXIMATELY 0.02 IN LENGTH. NO OTHER CABLE DAMAGE WAS FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPROCESSING THAT THE TIPS DID NOT ALIGN ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94924 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 420172-07 M10121011 236

    Patients

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