BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERT

    MDR report key: 1905068 · Received November 22, 2010

    Report

    Report Number
    2955842-2010-00507
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 28, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K042855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARMONIC CURVED INSERT ACCESSORY WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE CUSTOMER REPORTED COMPLAINT AND FOUND THE INSERT TO BE RETURNED WITH THE CLAMP ARM DETACHED FROM THE DISTAL END. THE SHAFT FEATURE THAT MATES WITH THE CLAMP ARM PINS IS BENT BACKWARDS. THE INSERT SHOWED EVIDENCE OF OVERLOADING AND OR HYPEREXTENSION OF THE CLAMP ARM RESULTING IN THE BREAKAGE. NO OTHER DAMAGE WAS FOUND. ON (B)(6), 2010 (B)(6) STATED THAT 4 HARMONIC CURVED SHEAR (HCS) INSERTS BROKE DURING THE MYOMECTOMY CASE ON (B)(6) 2010. SHE STATED THAT THE SURGEON WAS TORQUING THE JAWS OF THE HCS INSERT TO TEAR TISSUE AWAY FROM THE MYOMA AND USING A HOOKING MOTION ON THE BOTTOM WHICH WAS CAUSING THE HCS INSERTS TO BREAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S MYOMECTOMY PROCEDURE THE HARMONIC CURVED SHEARS INSERT BROKE AND FELL INTO THE PATIENT. THE INSERT WAS RETRIEVED FROM THE PATIENT AND REPLACED. THE PROCEDURE CONTINUED AND THE REPLACEMENT HARMONIC CURVED SHEARS INSERT BROKE AND FELL INTO THE PATIENT. THE INSERT WAS RETRIEVED FROM THE PATIENT AND REPLACED. THE PROCEDURE CONTINUED USING THE THIRD HARMONIC CURVED SHEARS INSERT, HOWEVER, THE REPLACEMENT INSERT BROKE AND FELL INTO THE PATIENT. THE INSERT WAS RETRIEVED FROM THE PATIENT AND REPLACED. THE PROCEDURE CONTINUED USING THE FOURTH HARMONIC CURVED SHEARS INSERT, HOWEVER, THE REPLACEMENT INSERT BROKE AND FELL INTO THE PATIENT. THE INSERT WAS RETRIEVED FROM THE PATIENT, REPLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE FOLLOWING MEDWATCH REPORTS WERE SENT TO THE FDA IN RELATION TO THIS EVENT: 2955842-2010-00492, 2955842-2010-00506, 2955842-2010-00509.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400169-07 M10100719

    Patients

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