BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE

    MDR report key: 16916160 · Received May 11, 2023

    Report

    Report Number
    9610773-2023-01295
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Report Date
    November 8, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HRX
    UDI-DI
    04042761010535
    PMA / PMN Number
    K951354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO INFORM THAT UPON FURTHER REVIEW, THIS IS NOT A REPORTABLE MALFUNCTION. THE INITIAL MEDWATCH REPORTED THE SUBJECT DEVICE HAD A CRACKED LENS; HOWEVER; PER THE LEGAL MANUFACTURER, THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION REGARDING THE DETAILS OF THE EVENT WAS OBTAINED OR PROVIDED BY THE CUSTOMER. THE DEVICE HISTORY RECORDS FOR THE AFFECTED SERIAL NUMBER WAS REVIEWED WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. THE REFERENCED DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. ALTHOUGH NO EXTERNAL LENS WAS DAMAGED, THE INTERNAL OPTICAL LENS WAS FOUND DAMAGED (NON-REPORTABLE). ALSO, THE RIGID OUTER TUBE HAS DEFORMATION, AND CONTAMINATION/PARTICLES CAN BE SEEN INSIDE THE OPTICAL SYSTEM. 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): K944072 / K950076.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE TRUEVIEW II AUTOCLAVABLE RIGID TELESCOPE WAS FOUND TO HAVE A ¿LENS CRACK¿ DURING AN UNSPECIFIED EVENT. IT WAS REPORTED THE DIAGNOSTIC PROCEDURE WAS COMPLETED WAS COMPLETED AND NO DEATH, INJURY OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053810 TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE RIGID SCOPE HRX OLYMPUS WINTER & IBE GMBH A70940A 703003 04042761010535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown