BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7827140 · Received August 29, 2018

    Report

    Report Number
    3009185973-2018-00234
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 21, 2018
    Report Date
    June 14, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE NAVIGATED POINTER PROBE WAS FOUND TO BE BROKEN DURING A PREVENTATIVE MAINTENANCE. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE NAVIGATED POINTER PROBE WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. A VISUAL INSPECTION BY A HARDWARE ENGINEER CONFIRMED THAT THE TWO SUB-COMPONENTS OF THIS PART ARE DISASSEMBLED. THERE IS NO VISIBLE DAMAGE/SHOCK FOR THOSE TWO SUB-COMPONENTS. THIS PART HAS BEEN USED DURING ONE YEAR BEFORE THE PROBLEM WAS DETECTED, APPROXIMATELY FOR 50-60 SURGERIES. THE ROOT CAUSE OF THE DISASSEMBLY CAN NOT BE IDENTIFIED, THE MOST LIKELY ROOT CAUSE IS WEAR AND TEAR OF THE PART DUE TO REPEATED USES FOR SURGERIES AND STERILIZATION CYCLES. IT WAS PREVIOUSLY REPORTED IN THE INITIAL MEDWATCH REPORT THAT DEVICE BS17008 WAS SIMILAR TO DEVICE ROSA BRAIN 3.0 FDA CLEARED UNDER REFERENCE (B)(4). HOWEVER IT WAS INCORRECT, DEVICE BS17008 IS SIMILAR TO ROSA SPINE FDA CLEARED UNDER REFERENCE (B)(4).

    Description of Event or Problem · 0

    DURING A PREVENTIVE MAINTENANCE PERFORMED BY MEDTECH FIELD SERVICE ENGINEERS, A POINTER PROBE WAS FOUND DAMAGED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4). THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K172444.

    Description of Event or Problem · 1

    DURING A PREVENTIVE MAINTENANCE PERFORMED BY MEDTECH FIELD SERVICE ENGINEERS, A POINTER PROBE WAS FOUND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671755 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA POINTER PROBE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1