BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 19153252 · Received April 22, 2024

    Report

    Report Number
    3002808148-2024-32364
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 22, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170393204
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E3: NON-HEALTH CARE PROFESSIONAL; E2: NO BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: THE CAMERA CABLE WAS NOT AIRTIGHT DUE TO THE HOLE AND WATER ENTERED THE CAMERA CABLE, RESULTING IN FLOODING. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE CAMERA HEAD HAD A FLOODED CAMERA CABLE AND A HOLE IN THE CAMERA CABLE. THERE WAS NO PATIENT INVOLVEMENT. OTHER INFORMATION FROM SOURCE SYSTEM REPORT: IS_THIS_COMPLAINT: Y CUSTOMER_ACC_CODE: (B)(6). DOCUMENT TEXT: CH-S200-XZ-EA-J 7800618 CORRECTION_DESC_LOCAL_LANG: REPAIRED DEVICE 01:REGULAR REPAIR 06-MAR-2024, RECEIVED SOURCE UPDATE AS BELOW. SOURCE REPORT COLUMNS UPDATED AS BELOW: DOCUMENT TEXT: CH-S200-XZ-EA 7800618 PRODUCT_RECEIPT_DATE: 2024/03/05 08:58:00 CORRECTION_DESC_LOCAL_LANG: REPAIRED DEVICE 0J: REGULAR REPAIR (EQUIPMENT FREE OF CHARGE) THE CASE WAS UPGRADED TO COMPLAINT SINCE THERE ARE SPECIFIC COMPLAINTS OR CONCERNS ABOUT THE DEVICE KNOWN FROM MANUAL UPDATE. 07-MAR-2024, RECEIVED SOURCE UPDATE AS BELOW. 1. ATTACHMENTS ADDED. FILE NAME: ESTO_7102095058_1.PDF ESTC_7102095058_1.PDF 7102095058_SK_M1_¿¿_SKRLMD21.PDF 2. SOURCE REPORT COLUMNS UPDATED. THE FOLLOWING ARE THE DETAILS OF EACH UPDATE: 1. ATTACHMENTS ADDED. FILE NAME:ESTC_7102095058_1.PDF WATERTIGHTNESS CONFIRMATION REPAIR REQUEST: CABLE REPLACEMENT, CABLE SECTION, CABLE, WATER INVASION, RL648100 APPEARANCE CONFIRMATION ¿ REPAIR REQUEST: CABLE REPLACEMENT, CABLE SECTION, CABLE, SCRATCHED, RL648100 APPEARANCE CONFIRMATION ¿ REPAIR REQUEST: PACKING REPLACEMENT, HEAD SECTION, PACKING, DETERIORATION, RA133900 ATTACHMENTS ADDED. FILE NAME: ESTO_7102095058_1.PDF FCA CORRESPONDENCE, REOCCURRED CABLE SCRATCHED, WATER INVASION SW PACKING DETERIORATION AT THE TIME OF UNREPAIRED: FULL INSPECTION ATTACHMENTS ADDED. FILE NAME: 7102095058_SK_M1_¿¿_SKRLMD21.PDF ESTIMATE CONTENTS: ¿CUSTOMER INDICATION¿ CONFIRMATION OF OPERATION OF EACH FUNCTION, INSPECTION ¿RECEPTION INDICATION ITEMS¿ CABLE SECTION, CABLE, SCRATCHED, WATER INVASION, REPLACEMENT HEAD SECTION, PACKING, DETERIORATION, REPLACEMENT ARTICLE: NO CHARGE FOR LOANING REPLACEMENT ITEMS. PERFORMED AN INSPECTION OF THE SCREW SECTION AS REPORTED IN THE "IMPORTANT NOTICE REGARDING CAMERA HEAD RE-REPAIR". IT WAS REPORTED THAT NO ABNORMALITY WAS OBSERVED. U3/5. SHINADA. F. 2. SOURCE REPORT COLUMNS UPDATED AS BELOW: CORRECTION_DESC_LOCAL_LANG: REPAIRED DEVICE 0J: REGULAR REPAIR (EQUIPMENT FREE OF CHARGE) ¿CUSTOMER INDICATION¿ CONFIRMATION OF OPERATION OF EACH FUNCTION, INSPECTION ¿RECEPTION INDICATION ITEMS¿ CABLE SECTION, CABLE, SCRATCHED, WATER INVASION, REPLACEMENT HEAD SECTION, PACKING, DETERIORATION, REPLACEMENT EVALUATION_RESULT_LOCAL_LANG: ¿CUSTOMER INDICATION¿ CONFIRMATION OF OPERATION OF EACH FUNCTION, INSPECTION ¿RECEPTION INDICATION ITEMS¿ CABLE SECTION, CABLE, SCRATCHED, WATER INVASION, REPLACEMENT HEAD SECTION, PACKING, DETERIORATION, REPLACEMENT TRANSLATION OF INQUIRY RECORD DETERMINED AS A COMPLAINT DONE BY TRIAGE COMPLAINT EVALUATOR XINYU LUO FLUENT IN ENGLISH AND JAPANESE ON 07-MAR-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254426 HD 3CMOS AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S200-XZ-EA 04953170393204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown