BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSERT

    MDR report key: 2930196 · Received January 25, 2013

    Report

    Report Number
    2955842-2013-00289
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 27, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERT ACCESSORY WAS RETURNED AND EVALUATED. THE HARMONIC ACE CURVED SHEARS INSTRUMENT IS USED IN CONJUNCTION WITH THE HARMONIC ACE CURVED SHEARS INSERT ACCESSORY. INVESTIGATION BY FAILURE ANALYSIS SHOWED A MISSING TEFLON PAD AND BROKEN ROUND RACK FEATURE. INSERT WAS RETURNED INSTALLED ON THE HARMONIC ACE CURVED SHEARS INSTRUMENT. INSERT IS STUCK IN INSTRUMENT AND CANNOT BE REMOVED. VISUAL INSPECTION SHOWS THE ENTIRE TEFLON PAD IS MISSING FROM THE CLAMP ARM. NO DAMAGE OBSERVED TO THE CLAMP ARM GROOVE THAT HOLDS PAD. AT THE PROXIMAL END OF THE INSERT, THE ROUND RACK FEATURE IS BROKEN AROUND THE RETAINING RING GROOVE. RETAINING RING IS DETACHED FROM INSERT, MAKING INSERT REMOVAL FROM INSTRUMENT DIFFICULT. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE TO INSERT IS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. THE HARMONIC ACE CURVED SHEARS INSTRUMENT WAS RETURNED AND EVALUATED. CUSTOMER INITIALLY REPORTED TIP HAS A DENT. HOWEVER, FOR CLARIFICATION, THE NONCONFORMANCE WAS A DAMAGED SHAFT. SHAFT OF THE HARMONIC ACE CURVED SHEAR INSTRUMENT EXHIBITED NUMEROUS DENTS ON THE SHAFT. INSTRUMENT WAS RETURNED WITH THE ACE INSERT ALSO STILL INSTALLED WITH INSTRUMENT. ACE INSERT CANNOT BE REMOVED FROM INSTRUMENT. INSERT WAS LIKELY INSTALLED INCORRECTLY WITH EXCESSIVE FORCE, CAUSING BINDING OF THE INSERT AND INSTRUMENT. 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 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF REPORTED THE TIP OF THE HARMONIC ACE CURVED SHEARS INSTRUMENT USED IN CONJUNCTION WITH THE HARMONIC ACE CURVED SHEARS INSERT ACCESSORY HAD A DENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35584 HARMONIC ACE CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02 NA

    Patients

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