BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER INSTRUMENT

    MDR report key: 3900940 · Received June 27, 2014

    Report

    Report Number
    2955842-2014-03970
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE SNAKE WRIST CABLE BROKEN AT THE INSTRUMENT'S WRIST. ADDITIONALLY, THERE WAS A LARGE AREA OF SCRATCH MARKS / ABRASIONS MEASURING 1.435 X 0.282 WITH INSULATION REMOVED 4.61 FROM THE DISTAL END OF THE INSTRUMENT. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, WIRES WERE FRAYED AND INSULATION ON THE SHAFT WAS BROKEN/MISSING ON THE BOWL GRASPER INSTRUMENT. THE INSTRUMENT WAS NOT USED ON THE PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376839 BOWEL GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-05 S10140409 765

    Patients

    Seq Age Sex Outcome Treatment
    1