BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16713836 · Received April 11, 2023

    Report

    Report Number
    9610773-2023-01013
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 14, 2023
    Report Date
    July 17, 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
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. BASED ON THE RESULTS OF THE INVESTIGATION, THE ISSUE FOUND DURING INSPECTION (BLURRY IMAGE / DAMAGED LENS INSIDE OPTICAL SYSTEM) WAS LIKELY CAUSED BY EXCESSIVE FORCE BY THE DEVICE USER. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO G2 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE REPAIR INSPECTION FOUND THE BLACK EYEPIECE FUNNEL WAS CONFIRMED, HOWEVER, THE ABILITY TO REMOVE/DETACH THE EYEPIECE FUNNEL IS NORMAL WITH THIS MODEL; THEREFORE, THE FOLLOWING IS A NON-DEFECT. THE INSPECTION NOTED THE IMAGE IS BLURRY AND THE OPTICAL LENS INSIDE THE OPTICAL SYSTEM IS DAMAGED. 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. 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 RETURNED THE TRUEVIEW II, AUTOCLAVABLE TELESCOPE TO THE OLYMPUS REPAIR CENTER FOR A REPORTED EYEPIECE COMING OFF THAT WAS FOUND BY THE NURSE AT THE USER FACILITY DURING INSPECTION BEFORE AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, MENISCUS REPAIR VS DEBRIDEMENT PROCEDURE. AN ALTERNATE SCOPE WAS USED TO COMPLETE THE INTENDED PROCEDURE WITHOUT DELAY. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862266 TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE RIGID SCOPE HRX OLYMPUS WINTER & IBE GMBH A70941A 565782 04042761010542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown