BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)

    MDR report key: 15126455 · Received July 28, 2022

    Report

    Report Number
    9610595-2022-00399
    Event Type
    Injury
    Date Received
    July 28, 2022
    Report Date
    November 28, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FGB
    UDI-DI
    04953170063114
    PMA / PMN Number
    K912120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE THE RESULTS OF THE DEVICE EVALUATION, AND ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. AS A RESULT OF THE INSPECTION OF THE DEVICE, IT WAS FOUND THAT A WHITE STAIN ADHERED TO THE SCREW SECTION FOR MOUNTING THE KNOB FOR THE TIGHTENING OF THE FORCEPS/IRRIGATION PLUG (MAJ-891). AS A RESULT OF COMPONENT ANALYSIS OF THE STAIN, IT WAS FOUND TO BE A TYPE OF SILICIC ACID, WHICH CAN BE DERIVED FROM DRUGS OR TAP WATER. THE DEVICE HISTORY RECORD FOR THE SUBJECT DEVICE (MAJ-891) WAS UNABLE TO BE REVIEWED, SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE FOLLOWING POINTS WERE OBSERVED: - THE CUSTOMER PERFORMED A CULTURE TEST ON THE TWO SCOPES (CYF-VA2 AND CYF-VHA) AND NO BACTERIAL GROWTH WAS IDENTIFIED. - ACCORDING TO THE CULTURE TEST REPORT OF THE OER-S, THERE WAS NO GROWTH OF BACTERIA IDENTIFIED. - ESCHERICHIA COLI AND KLEBSIELLA PNEUMONIAE (GROWING COLONIES: 300) WERE DETECTED FROM THE FORCEPS/IRRIGATION PLUG THAT WAS USED IN COMBINATION WITH THE CYF-VHA. - THE RETURNED DEVICE HAD A SILICIC ACID STAIN. BASED ON THE DETECTED MICROORGANISMS AND THE WHITE STAIN, IT CAN BE CONCLUDED THAT THE MAJ-891 WAS INSUFFICIENTLY REPROCESSED. HOWEVER, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED ISSUES. THE DEVICE'S INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING WARNING REGARDING INAPPROPRIATE REPROCESSING: "IF THE FORCEPS/IRRIGATION PLUG IS NOT CLEANED METICULOUSLY, EFFECTIVE DISINFECTION OR STERILIZATION MAY NOT BE POSSIBLE. CLEAN THE FORCEPS/IRRIGATION PLUG THOROUGHLY BEFORE DISINFECTION OR STERILIZATION TO REMOVE MICROORGANISMS OR ORGANIC MATERIAL THAT COULD REDUCE THE EFFICACY OF DISINFECTION OR STERILIZATION." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION, ADDITIONAL RELATED COMPLAINTS, AND CORRECTED DATA. CORRECTED DATA: G3: INITIAL MDR MFR REPORT NUMBER 9610595-2022-00399, AWARE DATE IS 29JUN2022.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OVER THE LAST 1-2 MONTHS, A CLUSTER OF FIVE PATIENTS HAVE BEEN INFECTED WITH URINARY TRACT INFECTIONS AFTER ENDOSCOPY USING ONE OF TWO CYSTOSCOPES THAT WERE PROCESSED IN AN OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1 OF 5 -SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2 OF 5 -SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3 OF 5 -SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4 OF 5- SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5 OF 5- SCOPE (CYF-VHA). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SECOND SCOPE PROCESSED IN THE OER-S (CYF-VA2) (POTENTIAL FOR CROSS CONTAMINATION). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 1 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 2 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 3 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 4 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT INFECTION 5 OF 5 POTENTIALLY RELATED TO OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS POTENTIAL CROSS CONTAMINATION OF CYF-VA2 BY OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS POTENTIAL CROSS CONTAMINATION OF CYF-VA2 BY OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS POTENTIAL CROSS CONTAMINATION OF CYF-VA2 BY OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS POTENTIAL CROSS CONTAMINATION OF CYF-VA2 BY OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS POTENTIAL CROSS CONTAMINATION OF CYF-VA2 BY OER-S. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE MAJ-891 USED BY THE ORE-S FOR THE REPROCESSOR. MORE THAN A YEAR AGO, THERE WAS SOMETHING LIKE GREEN ALGAE GROWING ON THE WATER FILTER. IN VIEW OF THIS, THE FACILITY IS CONCERNED ABOUT INFECTION CAUSED BY OER-S. AT THAT TIME, THE FACILITY STAFF DID NOT FIND ANY ABNORMALITIES AFTER THE RESPONSE, SO THE PROCESS WAS COMPLETED WITHOUT ANY PROBLEMS, AND THERE WAS NO PROBLEM WITH THE FREQUENCY OF FILTER REPLACEMENT AT THE FACILITY NOTED. MICROBIOLOGICAL INVESTIGATION OF THE REPORTED REPROCESSOR INDICATES THE OER-S IS NOT THE SOURCE OF INFECTION IN THE REPORTED PATIENTS. ADDITIONAL DETAILS REGARDING THE PATIENTS AND REPORTED EVENTS HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: BACTERIA DETECTED IN THE MAJ-891 COULD LEAD TO SYMPTOMS IN THE INFECTED PATIENT. MAJ-891 WAS USED IN COMBINATION WITH THE SCOPE. THE FIVE PATIENTS DEVELOPED SYMPTOMS APPROXIMATELY TEN DAYS AFTER THE ENDOSCOPY. THE PATIENTS EXHIBITED FEVER, CHILLS, PAIN ON URINATION AND FREQUENT URINATION. PATIENTS WERE RE-EXAMINED AND PRESCRIBED ANTIBIOTICS AT THE TIME OF ENDOSCOPY. THE PATIENTS RECOVERED AFTER TEMPORARY HOSPITALIZATION FOR FEVER AND REPORTED AS 'GOOD.' THE PHYSICIAN POINTED OUT THE POSSIBILITY OF OLYMPUS EQUIPMENT DUE TO THE LARGE NUMBER OF PATIENTS WHO RETURNED TO SEE THE DOCTOR AFTER THE ENDOSCOPY. ADDITIONAL REPORTS BEING SUBMITTED FOR MAJ-891 AND EACH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1 OF 5 AND THE MAJ-891 USED BY THE ORE-S FOR THE REPROCESSOR. PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2 OF 5 AND THE MAJ-891 USED BY THE ORE-S FOR THE REPROCESSOR. PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 3 OF 5 AND THE MAJ-891 USED BY THE ORE-S FOR THE REPROCESSOR. PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 4 OF 5 AND THE MAJ-891 USED BY THE ORE-S FOR THE REPROCESSOR. PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 5 OF 5 AND THE MAJ-891 USED BY THE ORE-S FOR THE REPROCESSOR. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500134 FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) FORCEPS/ IRRIGATION PLUG FGB AIZU OLYMPUS CO., LTD. MAJ-891 UNKNOWN 04953170063114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other