BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEICA PROVEO 8

    MDR report key: 12566750 · Received October 4, 2021

    Report

    Report Number
    3003974370-2021-00019
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 21, 2021
    Report Date
    February 10, 2022
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    FSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FINAL REPORT. DURING THE ON-SITE INVESTIGATION BY THE FSE IT WAS FOUND THAT THE PROVEO 8 HAS NO DEFECTS AND FULLY CONFORMS TO ITS SPECIFICATION. THE OBSERVED ISSUE WAS NOT CAUSED BY A DEFICIENCY OF THE PROVEO 8. IDENTIFIED TECHNICAL ROOT CAUSE FOR THE OBSERVED ISSUE IS A DESIGN WEAKNESS OF THE 3RD PARTY LASER FILTER MADE BY QUANTEL MEDICAL, MODEL: FMW. DUE TO THE SHAPE OF THE MECHANICAL INTERFACES OF THE 3RD PARTY LASER FILTER A RELIABLE FIXATION BETWEEN THE OPTICS CARRIER OF THE SURGICAL MICROSCOPE, THE 3RD PARTY LASER FILTER AND THE BINOCULAR TUBE CANNOT BE ENSURED. IF ONE OF THE FIXATION SCREWS WILL GET LOOSE THERE IS A LOW PROBABILITY FOR THE USER TO DETECT THE UNRELIABLE MECHANICAL FIXATION BEFORE THE 3RD PARTY LASER FILTER AND /OR THE BINOCULAR TUBE WILL FALL DOWN. CAPA-HER-MD-22-001 WAS INITIATED TO ADDRESS THIS ISSUE. THE MANUFACTURER OF THE 3RD PARTY LASER FILTER, QUANTEL MEDICAL, LOCATED IN FRANCE, WAS INFORMED BY LEICA MICROSYSTEMS (SCHWEIZ) AG ABOUT THE SITUATION, THE RESULT OF THE COMPLAINT INVESTIGATION AND THE INITIATION OF THE CAPA TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT. DURING THE ON-SITE INVESTIGATION BY THE FSE IT WAS FOUND THAT THE PROVEO 8 HAS NO DEFECTS AND FULLY CONFORMS TO ITS SPECIFICATION. THE OBSERVED ISSUE WAS NOT CAUSED BY A DEFICIENCY OF THE PROVEO 8. IDENTIFIED TECHNICAL ROOT CAUSE FOR THE OBSERVED ISSUE IS A DESIGN WEAKNESS OF THE 3RD PARTY LASER FILTER MADE BY QUANTEL MEDICAL, MODEL: FMW. DUE TO THE SHAPE OF THE MECHANICAL INTERFACES OF THE 3RD PARTY LASER FILTER A RELIABLE FIXATION BETWEEN THE OPTICS CARRIER OF THE SURGICAL MICROSCOPE, THE 3RD PARTY LASER FILTER AND THE BINOCULAR TUBE CANNOT BE ENSURED. IF ONE OF THE FIXATION SCREWS WILL GET LOOSE THERE IS A LOW PROBABILITY FOR THE USER TO DETECT THE UNRELIABLE MECHANICAL FIXATION BEFORE THE 3RD PARTY LASER FILTER AND /OR THE BINOCULAR TUBE WILL FALL DOWN. THE INVESTIGATION IS NOT YET COMPLETED. A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING INVESTIGATION.

    Description of Event or Problem · 1

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM GERMANY STATING THAT A LEICA BINOCULAR TUBE AND A 3RD PARTY LASER FILTER THAT WERE ATTACHED TO EACH OTHER FELL TO THE FLOOR. BOTH PARTS WERE MOUNTED ONTO THE PROVEO 8 OPTICS CARRIER, WITH THE LASER FILTER BEING INBETWEEN THE BINOCULAR TUBE AND THE OPTICS CARRIER. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468802 LEICA PROVEO 8 SURGICAL MICROSCOPE FSO LEICA MICROSYSTEMS (SCHWEIZ) AG PROVEO 8

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown