BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSERT

    MDR report key: 2021232 · Received March 16, 2011

    Report

    Report Number
    2955842-2011-00078
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K093217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERT ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT A SECTION OF THE CURVED BLADE HAD BROKEN OFF. A PIECE OF THE CURVED BLADE, MEASURING APPROXIMATELY .385 X .080, WAS MISSING AND NOT RETURNED WITH THE INSERT. THE FRACTURE SURFACE OF THE BLADE IS NOT LEVEL AND OUTER SURFACE OF BLADE HAS A COUPLE OF SCRATCH MARKS BELOW FRACTURE. IT WAS DETERMINED THAT THIS DAMAGE MAY HAVE CONTRIBUTED TO THE BLADE BREAKAGE SINCE THE BROKEN PIECE HAS SCRATCH MARKS IN THE AXIAL DIRECTION, CONSISTENT WITH THIS MOTION. ALTHOUGH INTUITIVE SURGICAL USES THE TERM BLADE ABOVE, THERE ARE NO COMPONENTS IN THE HARMONIC ACE CURVED SHEARS INSTRUMENTS OR INSERTS THAT MEET THE DEFINITION OF MEDICAL SHARPS. THE DA VINCI HARMONIC ACE CURVED SHEARS INSTRUCTIONS FOR USE SPECIFICALLY STATES: INSPECTION PRIOR TO USE EXAMINE THE DEVICE PRIOR TO USE. IN PARTICULAR, EXAMINE THE FOLLOWING COMPONENTS FOR CRACKS OR FLAWS: THE CLAMP ARM AND BLADE ON THE INSERT, THE SHAFT OF THE INSERT, THE REUSABLE INSTRUMENT HOUSING CAUTION: IF CRACKS OR FLAWS ARE OBSERVED, DO NOT USE THE DEVICE. NOTE: SCRATCHES ON THE BLADE MAY LEAD TO PREMATURE BLADE FAILURE. AVOID ACCIDENTAL CONTACT WITH OTHER INSTRUMENTS DURING USE. DO NOT USE ANY MEANS OTHER THAN THE BLADE WRENCH TO ATTACH OR DETACH THE INSTRUMENT FROM THE HAND PIECE. GENERAL PRECAUTIONS AND WARNINGS: DO NOT ATTEMPT TO BEND, SHARPEN, OR OTHERWISE ALTER THE SHAPE OF THE BLADE. DOING SO MAY CAUSE BLADE FAILURE AND USER OR PATIENT INJURY. AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE DEVICE IS ACTIVATED. CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY A GENERATOR SOLID TONE OR AN INSTRUMENT ERROR. CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE BLADE AND CLAMP ARM WITHOUT HAVING TISSUE BETWEEN THEM. THIS CAN RESULT IN POSSIBLE DAMAGE TO THE INSTRUMENT. BOTH CONDITIONS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER OF THE FOOT PEDALS IS DEPRESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S ABDOMINOPERINEAL RESECTION PROCEDURE THE TIP OF THE HARMONIC ACE CURVED SHEARS INSERT BROKE AND A PIECE FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM & ACCS., HARMONIC ACE INST., ES