BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M320 W12

    MDR report key: 16821183 · Received April 27, 2023

    Report

    Report Number
    3003974370-2023-00008
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    March 31, 2023
    Report Date
    April 27, 2023
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A COMBINED INITIAL/FINAL REPORT. LEICA MICROSYSTEMS (SCHWEIZ) AG (HEREINAFTER REFERRED TO AS LMS) INVESTIGATED THE REPORTED INCIDENT BASED ON PROVIDED INFORMATION SUCH AS PICTURES, LMS SERVICE ENGINEER AND CUSTOMER FEEDBACK. IT WAS FOUND THAT THE AFFECTED M320 W12 WAS NOT MOUNTED WITH A WALL PLATE AS RECOMMENDED BY LMS. THE ORIGINAL CUSTOMER ORDER SHOWS THAT THE M320 W12 WALL PLATE SET - METAL STUD WALL, WAS ORDERED ACCORDING TO THE PLANNING DOCUMENTATION. THE FIXATION OF THE DEVICE WAS PERFORMED WITH THE WALL PLATE ACCORDING TO THE INSTALLATION MANUAL. FROM THE DISCUSSION WITH THE USER, WE LEARNED THAT THE M320 W12 HAS BEEN MOVED FROM ITS ORIGINAL LOCATION TO ANOTHER ROOM. THE WALL PLATE MENTIONED ABOVE WAS NOT FITTED TO REINSTALL THE M320 W12 IN ITS NEW LOCATION. THIS MOVE WAS PERFORMED BY A SERVICE PROVIDER NOT AUTHORIZED BY LMS. LMS HAS NOT BEEN NOTIFIED OF THE MOVE AND DOES NOT HAVE ACCESS TO THE AFFECTED DEVICE'S SERVICE HISTORY. THE SERVICE PROVIDER NOT AUTHORIZED BY LMS DID NOT FOLLOW THE REQUIREMENTS AND RECOMMENDATIONS STATED IN THE PLANNING DOCUMENTATION AND THE INSTALLATION MANUAL. IN ADDITION, LMS WAS NOT INVOLVED IN THE RELOCATION OF THE SYSTEM. A REVIEW OF THE COMPLAINT STATISTIC REVEALED THAT THIS EVENT CAN BE CONSIDERED AN ISOLATED EVENT WITH NO SYSTEMIC OR ADVERSE TREND. THE INCIDENT CAN BE TRACED TO USER NOT FOLLOWING THE INSTRUCTIONS. LMS HAS BEEN REQUESTED BY THE CUSTOMER TO CORRECTLY MOUNT THE AFFECTED M320 W12 USING THE RECOMMENDED WALL PLATE. LMS WILL ORDER THE REQUIRED PARTS AND PERFORM THE PROPER REINSTALLATION ONCE ALL PARTS ARE AVAILABLE AND CONFIRM AN APPOINTMENT WITH THE CUSTOMER.

    Description of Event or Problem · 0

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM USA STATING THAT A WALL MOUNTED M320 W12 CAME OFF THE WALL DURING USE. THERE WAS NO PATIENT / USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558317 M320 W12 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M320 W12

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown