BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS SIGMOIDOFIBERSCOPE

    MDR report key: 1812571 · Received August 18, 2010

    Report

    Report Number
    8010047-2010-00161
    Event Type
    Other
    Date Received
    August 18, 2010
    Report Date
    July 20, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADD'L INFO REGARDING THIS REPORT, BUT ONLY LIMITED INFO WAS PROVIDED. THE USER FACILITY REPORTED THAT A TOTAL OF FIVE PATIENTS COMPLAINED OF ALLERGIC REACTIONS POST SIGMOIDOSCOPY. FOUR OUT OF THE FIVE PATIENTS REPORTEDLY DEVELOPED HIVES, AND ONE PATIENT COMPLAINED OF SHORTNESS OF BREATH. THE FIFTH PATIENT WAS IMMEDIATELY TAKEN TO EMERGENCY ROOM OF A NEARBY HOSPITAL, BUT WAS NOT ADMITTED. THE PHYSICIAN AT THE EMERGENCY ROOM COULD NOT DETERMINE THE CAUSE OF THE PATIENTS REACTION. ALL FIVE PATIENTS REFERENCED IN THIS REPORT. THERE WAS NO FURTHER INFO PROVIDED BY THE USER FACILITY. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBTAIN MORE INFO, AND TO ASSESS THE REPROCESSING PRACTICES AT THE USER FACILITY. THE ESS REPORTED THAT CONFLICTING INFO WAS PROVIDED TO HIM BY DIFFERENT STAFF MEMBERS AT THE USER FACILITY. HOWEVER, THE ESS DETERMINE THAT BASED ON THE INFO PROVIDED, THAT USER FACILITY PERSONNEL WERE NOT REPROCESSING THEIR SIGMOIDOSCOPES IN ACCORDANCE WITH THE RECOMMENDED REPROCESSING PROTOCOL. THE ESS PROVIDED INSERVICE TRAINING REGARDING APPROPRIATE REPROCESSING OF ENDOSCOPES AND PROVIDED EDUCATIONAL MATERIALS. THE USER FACILITY IS REPORTEDLY PURCHASING ADD'L EQUIPMENT AND REPROCESSING SUPPLIES INCLUDING AN AUTOMATED ENDOSCOPE REPROCESSOR (AER). THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION. SEE MFR # 8010047-2010-00162 FOR A RELATED REPORT.

    Description of Event or Problem · 1

    USER FACILITY PERSONNEL REPORTED THAT SEVERAL PATIENTS HAD REPORTEDLY COMPLAINED OF AN ALLERGIC REACTION FOLLOWING SIGMOIDOSCOPY OVER A PERIOD OF SEVERAL MONTHS. OLYMPUS WAS INFORMED THAT SIGMOIDOSCOPES AT THE USER FACILITY WERE NOT BEING REPROCESSED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AND THE USER FACILITY WAS SIGNIFICANTLY DEVIATING FROM THE RECOMMENDED CLEANING INSTRUCTIONS INCLUDING NOT PERFORMING PRE-CLEANING, LEAK TESTING, NOR COMPLETELY SUBMERGING THE ENDOSCOPE INTO REPROCESSING CHEMICALS. THE USER FACILITY WAS ALSO REPORTEDLY INSUFFICIENTLY BRUSHING AND FLUSHING THE SIGMOIDOSCOPES CHANNELS, AND WAS EXPOSING THE DEVICES TO REPROCESSING CHEMICALS FOR VARYING LENGTHS OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SIGMOIDOFIBERSCOPE SIGMOIDOFIBERSCOPE FAM OLYMPUS MEDICAL SYSTEM CORPORATION OSF-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1