BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3890633 · Received June 24, 2014

    Report

    Report Number
    2955842-2014-03851
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 12, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S PITCH CABLE TO BE BROKEN. THE PITCH CABLE WAS BROKEN AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE BROKEN STRANDS WERE OBSERVED TO BE STICKING OUT AT THE WRIST OF THE INSTRUMENT. THE OTHER CABLES AT THE WRIST OF THE INSTRUMENT WERE UNDAMAGED. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING DAMAGES: THE BIPOLAR PINS WERE BENT. BOTH PINS WERE BENT AT THE BACKEND OF THE HOUSING. THE BIPOLAR INSERT WAS STILL INTACT. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. FAILURE ANALYSIS CONCLUDED THAT THE BENT DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. IN ADDITION, THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL.. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN CABLE AND THE VARIOUS SCRATCH MARKS ON THE MAIN TUBE WITH LIGHT MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI CYSTECTOMY SURGICAL PROCEDURE, A BROKEN CABLE WAS OBSERVED ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368139 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M12130508 588

    Patients

    Seq Age Sex Outcome Treatment
    1