BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE

    MDR report key: 16765622 · Received April 18, 2023

    Report

    Report Number
    9610773-2023-01069
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 19, 2023
    Report Date
    July 19, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HRX
    UDI-DI
    04042761010542
    PMA / PMN Number
    K951354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE E1 "TELEPHONE NUMBER" WAS CORRECTED DUE TO INCORRECT COUNTRY CODE FORMAT. THE G2 FIELD WAS CORRECTED AS "USER FACILITY" AND "OTHER" HAD NOT BEEN SELECTED. AN OLYMPUS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AT THE CUSTOMER SITE, AND THE REPORTABLE MALFUNCTION WAS CONFIRMED; THE EYEPIECE WAS MISSING FROM THE TELESCOPE BODY. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE EVENT IS DUE TO USER ERROR, SINCE THE CUP OF THIS PRODUCT IS NOT GLUED. THE CUP CAN BE REMOVED TO USE THE QUICK-COUPLING CONNECTOR. THEREFORE THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATION; NO PROBLEM FOUND. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING DATE AND THE SALES DATE FOR THE AFFECTED DEVICE COULD NOT BE OBTAINED. THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K944072/ K950076.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE WAS SENT IN FOR REPAIR. DURING INITIAL INSPECTION OF THE DEVICE, THE EYEPIECE WAS FOUND MISSING. THE REPORTED ISSUE OCCURRED DURING MAINTENANCE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS. THIS MEDWATCH IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624522 TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE RIGID SCOPE HRX OLYMPUS WINTER & IBE GMBH A70941A 220472K 04042761010542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown