BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8499452 · Received April 10, 2019

    Report

    Report Number
    3009185973-2019-00139
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Report Date
    November 25, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    OLO
    PMA / PMN Number
    N/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 GUIDE WIRE NAVIGATION REFERENCE WAS FOUND TO BE BROKEN DURING A SURGICAL PROCEDURE. DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW WERE NOT PERFORMED BASED ON THE LOW SEVERITY OF THIS COMPLAINT. THIS REPORTED FAILURE IS CONFIRMED BASED ON THE PICTURES RECEIVED FROM THE PART. THERE WAS NO PARTICULAR PRECIPITATING EVENT. THE REPORTER STATED THAT A POTENTIAL ROOT CAUSE COULD AN IMPORTANT NUMBER OF STERILIZATION CYCLES, AS REPORTEDLY THE PART WENT THROUGH 100+ STERILIZATION CYCLES. THIS PART WAS MANUFACTURED ON 08-AUG-2016 AND WAS INSTALLED AT THE CUSTOMER SITE ON 09-AUG-2017, AT THE SAME TIME THAN THE CORE DEVICE. AS THE ISSUE WAS NOTED ON THE 12-MAR-2019, THE PART WAS IN USE FOR MORE THAN ONE YEAR AND A HALF BEFORE THE FAILURE OCCURRED. NO INSPECTION OR TESTING OF THE DEVICE WAS PERFORMED AT THE MANUFACTURING SITE AS THE PART HAS NOT BEEN RETURNED, AND ITS LOCATION IS UNKNOWN. ON THIS OCCASION, IS IT NO POSSIBLE TO DETERMINE THE CAUSE OF THE FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDEWIRE NAVIGATION HANDLE BROKEN DURING A SURGERY. THERE WAS NO IMPACT ON THE PATIENT, ONLY A 5 MINUTES DELAY TO OPEN A SECOND SET.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE MODEL ROSA ONE SPINE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA SPINE CLEARED UNDER K151511.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDEWIRE NAVIGATION HANDLE BROKEN DURING A SURGERY. THERE WAS NO IMPACT ON THE PATIENT, ONLY A 5 MINUTES DELAY TO OPEN A SECOND SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295018 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE OLO MEDTECH SA GUIDEWIRE NAVIGATION HANDLE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1