BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS OES-PRO TELESCOPE

    MDR report key: 3008724 · Received March 11, 2013

    Report

    Report Number
    9610773-2013-00025
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING BUT WITH NO RESULT. OLYMPUS FOLLOWED UP WITH THE REPORTER TO OBTAIN MORE INFO AND WAS INFORMED THAT DURING THE PROCEDURE, THE USER HAD USED A PRESSURE MACHINE WITH THE BIPOLAR BUTTON TURP PROCEDURE. THE REPORTER FURTHER STATED THAT THE USER FACILITY DID NOT SUSPECT THE OLYMPUS EQUIPMENT TO BE THE CAUSE OF THE PT'S OUTCOME. THE SUBJECT DEVICE AND ASSOCIATED OLYMPUS DEVICES WERE NOT RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE PT OUTCOME REMAINS UNK. THIS REPORT WILL BE SUPPLEMENTED IF ADDITIONAL AND SIGNIFICANT INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A BUTTON TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) SURGERY, A PT ALLEGEDLY SUFFERED A BLADDER PERFORATION AND DIED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101921 OLYMPUS OES-PRO TELESCOPE TELESCOPE FBP OLYMPUS WINTER & IBE GMBH A22002A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death A2027A, SN#UNK| (B)(4), LOT# UNK| CONMED PRESSURE MACHINE, MODEL/SN# UNK| GYRUS GENERATOR, MODEL 744000, SN# UNK| A22041T, SN#UNK