BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI VARIO 700

    MDR report key: 9684665 · Received February 7, 2020

    Report

    Report Number
    9615010-2020-00002
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    January 9, 2020
    Report Date
    January 9, 2020
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    FSO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAD A MALFUNCTION OF THE LEFT HAND-GRIP WHICH WAS KNOWN TO THE CUSTOMER BEFORE THIS INCIDENT OCCURRED. CARL ZEISS MEDITEC WAS NOT INFORMED BEFORE 9TH OF JANUARY ABOUT THE DEVICE MALFUNCTION. THE SAME DAY THE INCIDENT WAS REPORTED TO CARL ZEISS MEDITEC, A ZEISS FSE WENT ON CUSTOMER SITE AND EVALUATED THE DEVICE. ZEISS FSE WAS ABLE TO REPRODUCE THE ERROR WITH THE HAND-GRIP. THE HAND-GRIP UNIT LEFT SIDE WAS REPLACED. AFTER THE REPAIR, THE DEVICE MEETS FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020 A TOTAL FAILURE OF BOTH HAND GRIPS OCCURRED AT THE BEGINNING OF SPINE SURGERY, AN ERROR WHICH HAD OCCURRED A FEW DAYS BEFORE, ON (B)(6) 2020. PATIENT WAS UNDER ANESTHESIA FOR 30 MINUTES AND THE SURGERY WAS ABORTED. SURGERY WAS SUCCESSFULLY PERFORMED THE FOLLOWING DAY. THE PATIENT HAD TO STAY ONE DAY LONGER IN THE HOSPITAL. THERE WAS NO INJURY TO THE PATIENT DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143220 OPMI VARIO 700 MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY FSO CARL ZEISS MEDITEC AG (OBERKOCHEN) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1