BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 8163604 · Received December 14, 2018

    Report

    Report Number
    3009185973-2018-00338
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    November 16, 2018
    Report Date
    June 28, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K182417
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PATIENT CODE(S) : 3189 : REVERT TO TRADITIONAL SURGERY, SURGERY EXTENDED BY 30 MINUTES. INVESTIGATION CONCLUSION : IT WAS REPORTED THAT THE ROBOT ARM WAS NOT MOVEABLE ANYMORE DURING THE PROCEDURE. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ANALYSIS IDENTIFIED 2 ROOT CAUSES THAT MIGHT BE AT THE ORIGIN OF THE REPORTED EVENT : - A KNOWN DESIGN DEFECT THAT WAS CONFIRMED - A TRANSIENT ISSUE WITH THE FORCE SENSOR WHICH MIGHT HAVE MALFUNCTIONED AFTER AN EXPOSURE TO WATER DURING THE SURGERY. THIS HYPOTHESIS COULD NOT BE CONFIRMED, BUT WOULD BE ATTRIBUTABLE TO A USE ERROR, SINCE THE IFU PROVIDES CLEAR INDICATIONS REGARDING THE CORRECT DRAPING OF THE ROBOT ARM.

    Description of Event or Problem · 0

    DURING THE ENDOSCOPY THE DEVICE SHUT DOWN WITH A SYSTEM ERROR. AFTER THE RESTART THE FORCE SENSOR WAS CALIBRATED WITH THE ENDOSCOPE ON TOP. THE CLEARANCE PROCEDURE WAS STARTED. THE SURGEON TRIED TO MOVE THE ROBOT USING FREE FAST, BUT WAS NOT ABLE TO. RESTARTING THE DEVICE SEVERAL TIMES DID NOT HELP. ATIDAQ SHOWED NO MOVEMENT ON THE FORCE WHEN FORCE WAS APPLIED TO THE SENSOR. THE SURGEON HAD TO FINISH THE CASE MANUALLY. THE FSE CONFIRMED THAT THE SURGEON HAD TO REVERT TO TRADITIONAL SURGERY AS HE COULD NOT MOVE THE ARM ANY MORE IN COOPERATIVE MODE. THE SURGEON DID NOT NOTICED ANY ADVERSE EFFECT DUE TO THE ISSUE, HOWEVER THE SURGERY WAS EXTENDED BY 30 MINUTES. THE FSE ADDED INFORMATION REGARDING THE EVENT : AFTER UNDRAPING THE FORCE SENSOR WAS WET. DURING THE SURGERY, THE SURGEON FLUSHED THROUGH THE ENDOSCOPE THE WHOLE TIME. THERE WAS A BIT WATER RUNNING DOWN INSIDE THE DRAPE

    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.  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. (B)(4).

    Description of Event or Problem · 1

    DURING THE ENDOSCOPY THE DEVICE SHUT DOWN WITH A SYSTEM ERROR. AFTER THE RESTART THE FORCE SENSOR WAS CALIBRATED WITH THE ENDOSCOPE ON TOP. THE CLEARANCE PROCEDURE WAS STARTED. THE SURGEON TRIED TO MOVE THE ROBOT USING FREE FAST, BUT WAS NOT ABLE TO. RESTARTING THE DEVICE SEVERAL TIMES DID NOT HELP. ATIDAQ SHOWED NO MOVEMENT ON THE FORCE WHEN FORCE WAS APPLIED TO THE SENSOR. THE SURGEON HAD TO FINISH THE CASE MANUALLY. THE FSE CONFIRMED THAT THE SURGEON HAD TO REVERT TO TRADITIONAL SURGERY AS HE COULD NOT MOVE THE ARM ANY MORE IN COOPERATIVE MODE. THE SURGEON DID NOT NOTICE ANY ADVERSE EFFECT DUE TO THE ISSUE, HOWEVER THE SURGERY WAS EXTENDED BY 30 MINUTES. THE FSE ADDED INFORMATION REGARDING THE EVENT : AFTER UNDRAPING THE FORCE SENSOR WAS WET. DURING THE SURGERY, THE SURGEON FLUSHED THROUGH THE ENDOSCOPE THE WHOLE TIME. THERE WAS A BIT WATER RUNNING DOWN INSIDE THE DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004470 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1