BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7036292 · Received November 16, 2017

    Report

    Report Number
    3009185973-2017-00799
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    November 3, 2017
    Report Date
    October 31, 2018
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. VISUAL INSPECTION PERFORMED ON SITE BY A COMPANY REPRESENTATIVE ON THE DATE OF EVENT INDICATED THAT NOTHING SEEMED VISUALLY BENT OR DAMAGED. REPRESENTATIVE GUESSED THAT ONE OF THE TWO GUTTERS OR THE ADAPTOR MAYBE GOT SLIGHTLY BENT DURING MANUFACTURING, TRANSPORTATION, OR DURING ON-SITE STORAGE. HOWEVER AS THE PART WAS NOT RETURNED TO MANUFACTURING SITE FOR EVALUATION THE ROOT CAUSE FOR THE EVENT CAN NOT BE DETERMINED. A NEW ADAPTOR HAS BEEN INSTALLED AT THE CUSTOMER LOCATION, SINCE THEN THERE WAS NO FURTHER SIMILAR COMPLAINT RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ROSA ONE BS16007 IS NOT FDA APPROVED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW - K151359. THE DEVICE BS16007 HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A USER TRAINING IT WAS NOTICED THAT THE LEKSELL FRAME WAS NOT FULLY LOCKED INSIDE THE FRAME ADAPTOR, EVEN THOUGH THE LOCKING SCREWS AND JAWS WERE TIGHTENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A USER TRAINING, IT WAS NOTICED THAT THE LEKSELL FRAME WAS NOT FULLY LOCKED INSIDE THE FRAME ADAPTOR, EVEN THOUGH THE LOCKING SCREWS AND JAWS WERE TIGHTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817773 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA LEKSELL FRAME ADAPTOR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1