BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER LED SAPHIRA, OPAL1 PDD

    MDR report key: 18488837 · Received January 10, 2024

    Report

    Report Number
    9610617-2024-00001
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    December 19, 2023
    Report Date
    May 29, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OAY
    PMA / PMN Number
    P050027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER INVESTIGATION BY THE MANUFACTURING SITE: NO TECHNICAL ROOT CAUSE CAN BE EVALUATED. THE PRODUCT WORKS AS DESIGNED AND DESCRIBED IN THE IFU. THE MOST PROBABLE ROOT CAUSE: IT IS ASSUMED, THAT THE UNIT WAS STRONGLY IMPACTED FROM OUTSIDE, WHICH LED TO THE FRONT GLASS SHATTERING. THE SHARP EDGES OF THE BROKEN/SHATTERED GLASS LEAD TO THE HURT/ CUT OF THE OPERATOR'S HAND. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE A CASE ON DEC-19-2023, AN EMPLOYEE WAS CUT HANDLING THE DEVICE (THE FRONT OF THE DEVICE WAS BROKEN). THERE WAS NO PATIENT INVOLVEMENT, AND NO FURTHER INFORMATION WAS PROVIDED ABOUT THE INJURY OF THE EMPLOYEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638696 POWER LED SAPHIRA, OPAL1 PDD LED LIGHT SOURCE OAY KARL STORZ SE & CO. KG TL410US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other