BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSERT

    MDR report key: 3822046 · Received May 20, 2014

    Report

    Report Number
    2955842-2014-03108
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 27, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARMONIC ACE CURVED SHEARS INSERT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE BLADE WAS BROKEN AND THE BROKEN FRAGMENT WAS NOT RETURNED WITH THE INSTRUMENT. IT WAS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE TIP OF THE HARMONIC ACE CURVED SHEARS INSERT BROKE OFF AND FELL INTO THE PATIENT. PER THE INFORMATION PROVIDED, THE FALLEN TIP WAS RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEPATECTOMY PROCEDURE USING A DA VINCI SURGICAL SYSTEM, ONE OF THE TIPS OF THE HARMONIC ACE CURVED SHEARS INSERT BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS IMMEDIATELY RETRIEVED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. ON (B)(4) 2014, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE DISTRIBUTOR OF THIS COMPLAINT. THE DISTRIBUTOR INDICATED THAT THE FRAGMENT WAS REMOVED USING A DA VINCI INSTRUMENT. THE INSTRUMENT HAD BEEN IN USE OFF AND ON DURING THE CASE. THE SURGEON WAS PERFORMING LIVER REMOVAL AT THE TIME OF THE EVENT. THE DISTRIBUTOR DENIED ANY INSTRUMENT COLLISIONS AND DENIED ANY X-RAYS WERE PERFORMED AS A RESULT OF THE REPORTED EVENT. HE ALSO DENIED THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300451 HARMONIC ACE CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1