BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 165835 · Received April 30, 1998

    Report

    Report Number
    8010047-1998-00010
    Event Type
    Other
    Date Received
    April 30, 1998
    Date of Event
    March 3, 1998
    Report Date
    March 23, 1998
    Manufacturer
    OLYMPUS OPTICAL CO., LTD.
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S EVALUATION SUMMARY IF THE INFO SUBMITTED BY THE REPORTING HOSPITAL REGARDING THE ENDOSCOPE USED DURING THE PROCEDURE DESCRIBED IN THE MDR IS PROVIDED BELOW. THE MFR REPORTED THAT THE OLYMPUS INTUBATION FIBERSCOPE DOES NOT HAVE AN O-RING AROUND THE DISTAL TIP OF THE INSERTION TUBE. THE REPORTING HOSPITAL HAD STATED THAT AN O-RING HAD FALLEN INTO THE PT'S BRONCHUS. THE MANUFACTURER STATEDIT MUST BE ASSUMED THAT IF AN 0-RING HAD FALLEN INTO THE PATIENT'S BRONCHUS, IT WOULD HAVE BEEN FROM AN ENDO-THERAPY DEVICE. OLYPUS ENDO THERAPY DEVICES WITH O-RINGS ARE THE CD-10/20Z HEAT PROBES. THESE DEVICES ARE USED WITH A SCOPE WITH A 2.8 CHANNEL. BASED ON THE SMALL SIZE OF THE CHANNEL OF THE INTUBATION FIBERSCOPE, THE MANUFACTURER HAS CONCLUDED THAT IF THE PIECE WAS AN O-RING, IT WAS NOT FROM AN OLYMPUS PRODUCT. CO CALLED THE CUSTOMER TODAY TO NOTIFY HER OF THE MANUFACTURER'S REPORT. THE NURSE STATED THAT THE PIECE THAT HAD FALLEN INTO THE PATIENT'S BRONCHUS COULD HAVE BEEN A PIECE OF RUBBER AND NOT AN O-RING. OLMPUS AGREES THAT THE PIECE COULD HAVE BEEN PART OF A-RUBBER ESPECIALLY SINCE THE NURSE HAD ORIGINALLY REPORTED THAT THE PREVIOUS REPAIR PERFORMED BY THIRD PARTY HAD BEEN INFERIOR TO OLYMPUS REPAIRS. NO FURTHER ACTION WILLBE TAKEN AND THE COMPLAINT HAS BEEN CLOSED.

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE FOR CHECKING THE LOCATION OF A DOUBLE LUMEN ENDO-TRACHEAL TUBE, THE O-RING AT THE DISTAL TIP OF THE BRONCHOSCOPE FELL OFF INTO THE PT'S BRONCHUS. WHEN THE PIECE WAS NOTICED, THE PROCEDURE HAD ALREADY BEEN COMPLETED. THE PIECE WAS SUCCESSFULLY RETRIEVED AND THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS INTUBATION FIBERSCOPE EQN OLYMPUS OPTICAL CO., LTD. LF-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN