BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS OES BRONCHOFIBERSCOPE

    MDR report key: 1638834 · Received March 18, 2010

    Report

    Report Number
    8010047-2010-00051
    Event Type
    Injury
    Date Received
    March 18, 2010
    Date of Event
    February 2, 2010
    Report Date
    February 16, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT; HOWEVER, THE USER FACILITY PROVIDED LIMITED AND SOMETIMES CONFLICTING INFO. THE MEDWATCH FORM REPORTED A SINGLE INFECTION; HOWEVER, ONE STAFF AT THE FACILITY REPORTED A "COUPLE" OF INFECTIONS HAD OCCURRED. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. REVIEW OF THE INSTRUMENT HISTORY FOR THIS DEVICE REVEALED THAT IT WAS INITIALLY SHIPPED TO THE USER FACILITY ON 12/15/1992, AND LAST SERVICED ON 01/30/2006 WHEN IT HAD RECEIVED A COMPLETE REFURBISHMENT. OLYMPUS REPS HAD OFFERED AN IN-SERVICE TO REASSESS THE FACILITY'S REPROCESSING PRACTICES AND TO PROVIDE NECESSARY EDUCATIONAL SERVICES TO THE USER FACILITY'S PERSONNEL, IF NECESSARY. HOWEVER, THE USER FACILITY DECLINED THE OFFER. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. IF ADD'L SIGNIFICANT INFO BECOMES AVAILABLE LATER, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. CROSS-REFERENCE MFR REPORT NUMBERS: 8010047-2010-00049, 00050, AND 00052 FOR RELATED REPORTS.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH FORM STATING: "PT UNDERWENT A BRONCHOSCOPY, BIOPSY, AND BILATERAL BRONCHOALVEOLAR LAVAGE WITH ROUTINE CULTURES ORDER FROM OUR FACILITY (HOSPITAL #1). PT TOLERATED THE PROCEDURE AND WAS DISCHARGED HOME FROM RECOVERY ROOM. TWO DAYS LATER, THE PT SEEN AT ER OF HOSPITAL #2 FOR SHORTNESS OF BREATH. HOSPITAL #2 TRANSFERRED PT TO HOSPITAL #3 FOR ADMISSION. CULTURES DONE BY ER IN HOSPITAL #2 LATER TESTED POSITIVE FOR PSEUDOMONAS. HOSPITAL #3 CULTURES FOR PSEUDOMONAS WERE NEGATIVE. CULTURES FROM HOSPITAL #1 RETURNED THREE DAYS AFTER PT'S PROCEDURE WERE POSITIVE FOR PSEUDOMONAS AERUGINOSA. THIS INFO WAS RELAYED TO HOSPITAL #3. PT HAS ENCEPHALOPATHY AND IS IN RENAL FAILURE. SUBSEQUENT TO HIGH LEVEL DISINFECTION, BRONCHOSCOPE FROM OUR FACILITY DID NOT TEST POSITIVE FOR PSEUDOMONAS. (TESTED 9 DAYS AFTER ORIGINAL PT'S PROCEDURE.)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS OES BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORPORATION BF-P30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR