BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE

    MDR report key: 16799603 · Received April 24, 2023

    Report

    Report Number
    9610773-2023-01127
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Report Date
    July 25, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HRX
    UDI-DI
    04042761010559
    PMA / PMN Number
    K950076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY THE REPORTED EVENT OCCURRED DUE TO THE USE OF EXCESSIVE FORCE FROM IMPROPER HANDLING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE OBJECTIVE LENS AT THE DISTAL END OF THE SCOPE IS DAMAGED/SCRATCHED AND THE DISTAL TIP EDGE IS DAMAGED/CHIPPED. THE REVIEW OF THE DEVICE HISTORY RECORDS FOR THE AFFECTED LOT OR SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. HOWEVER, THE MANUFACTURING DATE OF THE CONCERNED DEVICE COULD NOT BE DETERMINED. THE DEVICE WAS SOLD FOR DISTRIBUTION ON (B)(6) 2004. THE INVESTIGATION IS STILL IN PROGRESS; HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. ADDITIONAL 510(K): K951354 / K944072.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE DISTAL TIP OF THE SCOPE IS DAMAGED AND ¿LENS CHIPPING¿. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT REPROCESSING AFTER A THERAPEUTIC ARTHROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME SCOPE WITHOUT DELAY. THE SCOPE WAS INSPECTED BEFORE USE WITH NO ABNORMALITY REPORTED. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685023 TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE RIGID SCOPE HRX OLYMPUS WINTER & IBE GMBH A70942A 405102 04042761010559

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown