BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA SURGICAL DEVICE

    MDR report key: 7880863 · Received September 17, 2018

    Report

    Report Number
    3009185973-2018-00243
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 9, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PK101791
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT MULTIPLE COMMUNICATION FAILURES OCCURRED DURING THE SURGERY. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF DATA LOG DETERMINED THAT 6 SHUTDOWNS OCCURRED. FOR THE 6 SHUTDOWNS THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE TECHNICIAN WORKING FOR THE CHINESE DISTRIBUTOR INFORMED MEDTECH SA / ZIMMER BIOMET BY EMAIL ON SEPTEMBER 10TH 2018 THAT THE SURGICAL TEAM REPORTED SEVERAL REBOOTS DURING THE LAST MONTHS. LOG FILES BETWEEN JANUARY TO AUGUST 2018 WERE PROVIDED. THE SERVICING MANAGER ANALYZED EACH LOG TO DETECT REBOOTS. MULTIPLE OCCURRENCES HAVE BEEN IDENTIFIED FOR THE PROCEDURE OF AUGUST 09TH.

    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.

    Description of Event or Problem · 1

    THE TECHNICIAN WORKING FOR THE (B)(4) DISTRIBUTOR INFORMED MEDTECH SA / ZIMMER BIOMET BY EMAIL ON SEPTEMBER 10TH 2018 THAT THE SURGICAL TEAM REPORTED SEVERAL REBOOTS DURING THE LAST MONTHS. LOG FILES BETWEEN (B)(6) 2018 WERE PROVIDED. THE SERVICING MANAGER ANALYZED EACH LOG TO DETECT REBOOTS. MULTIPLE OCCURENCES HAVE BEEN IDENTIFIED FOR THE PROCEDURE OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721786 ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA 2.5.8 2.5.8.4

    Patients

    Seq Age Sex Outcome Treatment
    1