BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 1570431 · Received December 23, 2009

    Report

    Report Number
    9710055-2009-00018
    Event Type
    Other
    Date Received
    December 23, 2009
    Date of Event
    November 26, 2009
    Report Date
    November 26, 2009
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET SERVICE TECH EVALUATED THE BROKEN HANDLE AND REPAIRED THE DEVICE. BASED ON THE VISUAL EXAMINATION, THE STERILIZABLE HANDLE BECAME DAMAGED AFTER MULTIPLE REUSE AND STERILIZABLE CYCLES. THE STERILIZABLE HANDLE CONDITION IS TO BE VERIFIED BEFORE USE BY THE MEDICAL STAFF, AS DESCRIBED IN THE XTEN USER MANUAL (B) (4): "BEFORE REUSING THE HANDLE AFTER IT HAS BEEN STERILIZED, ALWAYS CHECK FOR CRACKS". MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    A PIECE OF GLASS COMING FROM THE STERILISABLE HANDLE OF AN INTEGRATED CAMERA OF THE SURGICAL LIGHT SYSTEM FELL DOWN DURING A SURGICAL PROCEDURE. THE HOSPITAL DID NOT REPORT ANY INJURIES. (B) (4). (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM FSY MAQUET S.A. XTEN

    Patients

    Seq Age Sex Outcome Treatment
    1