BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA SURGICAL DEVICE

    MDR report key: 6453330 · Received April 3, 2017

    Report

    Report Number
    3009185973-2017-00375
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    February 4, 2016
    Report Date
    October 9, 2017
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K101791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT IT WAS STATED IN THE VENT DESCRIPTION THAT: DURING A SURGERY, IT WAS IDENTIFIED THAT BIOPSY NEEDLE LENGTH SETTING BY THE SURGEON WAS NOT CORRECT. NO PATIENT IMPACT WAS REPORTED. FURTHER INVESTIGATION INTO THIS EVENT IT WAS CONFIRMED THAT ROSA DEVICE FUNCTIONED AS INTENDED, DID NOT MALFUNCTION AND DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE BIOPSY NEEDLES ARE NOT MEDTECH DEVICES. THE ROOT CAUSE OF THE EVENT IS THAT THE SURGEON PHYSICALLY SELECTED AN INCORRECT NEEDLE LENGTH. THE SURGEON STATES THAT THERE WERE NO PATIENT IMPACT. THE ERROR WAS NOTED DURING CONTROL SCAN.

    Additional Manufacturer Narrative · 1

    THE DEVICE (B)(4) HAS BEEN INSPECTED FOR INVESTIGATION PURPOSE. THE TESTS PERFORMED CONFIRMED THAT SURGEONS SET A BAD BIOPSY NEEDLE LENGTH.

    Description of Event or Problem · 1

    DURING A SURGERY, IT WAS IDENTIFIED THAT BIOPSY NEEDLE LENGTH SETTING BY THE SURGEON WAS NOT CORRECT. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235976 ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA 2.5.8

    Patients

    Seq Age Sex Outcome Treatment
    1