BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS OES 4000 TELESCOPE

    MDR report key: 3019494 · Received March 11, 2013

    Report

    Report Number
    9610773-2013-00026
    Event Type
    Death
    Date Received
    March 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FBP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND WAS INFORMED THAT A PT EXPIRED DURING AN UNSPECIFIED PROCEDURE WHERE OLYMPUS EQUIPMENT WAS USED. NO FURTHER INFORMATION WAS PROVIDED. THE SUBJECT DEVICE AND ASSOCIATED DEVICES WERE RETURNED TO OLYMPUS FOR EVAL. THE EVAL ON THE SUBJECT DEVICE NOTED A SHADOW AND BLUR ON THE IMAGE DUE TO A CRACKED OPTICAL SYSTEM LENS, AND DEBRIS UNDERNEATH THE OPTICAL SYSTEM LENS. IN ADDITION, THE OUTER TUBE WAS SLIGHTLY BENT, WHICH IS ATTRIBUTED TO PHYSICAL DAMAGE. THE RETURNED DEVICES WERE TESTED AS A SYSTEM AND NO MALFUNCTIONS WERE NOTED. THE DEVICES WERE RETURNED TO THE USER FACILITY UNREPAIRED PER THE USER FACILITY'S REQUEST. THE EXACT CAUSE OF THE PT OUTCOME REMAINS UNK. THIS REPORT WILL BE SUPPLEMENTED IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    THE USER FACILITY RETURNED THE SUBJECT DEVICE AND THE ASSOCIATED DEVICES TO OLYMPUS FOR INSPECTION DUE TO AN UNSPECIFIED PT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102760 OLYMPUS OES 4000 TELESCOPE TELESCOPE FBP OLYMPUS WINTER & IBE GMBH A1931A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death (B)(4), LOT# 12W| (B)(4), LOT# 074W| (B)(4), LOT# 05-3| (B)(4), LOT# 13W| (B)(4), LOT# 095W28| (B)(4), LOT# 13W| (B)(4), LOT# 13W