BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 16192141 · Received January 18, 2023

    Report

    Report Number
    9614641-2023-00075
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    December 20, 2022
    Report Date
    April 17, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FBK
    UDI-DI
    04953170422577
    PMA / PMN Number
    K902736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE INK SPREADING ISSUE COULD NOT BE DETERMINED. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING VERBIAGE, WHICH MAY HAVE PREVENTED THE PHENOMENON: ¿THE OPERATOR OF THIS INSTRUMENT MUST BE A PHYSICIAN OR MEDICAL PERSONNEL UNDER THE SUPERVISION OF A PHYSICIAN AND MUST HAVE RECEIVED SUFFICIENT TRAINING IN CLINICAL ENDOSCOPIC TECHNIQUE. THIS MANUAL DOES NOT EXPLAIN OR DISCUSS CLINICAL ENDOSCOPIC PROCEDURES. BEFORE USE, PREPARE AND INSPECT THE INSTRUMENT AS INSTRUCTED BELOW. SHOULD THE ANY IRREGULARITY BE OBSERVED, DO NOT USE THE INSTRUMENT; USE A SPARE INSTEAD. DAMAGE OR IRREGULARITY MAY COMPROMISE PATIENT OR USER SAFETY, FOR EXAMPLE:POSING AN INFECTION-CONTROL RISK, CAUSING TISSUE IRRITATION, PERFORATION, BLEEDING OR MUCOUS MEMBRANE DAMAGE, AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE. ¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    USER FACILITY REPORTED WITH AN ISSUE OF "INK SPREADING". CUSTOMER STATED "THE INK IS SPREADING EVERYWHERE EXCEPT WHERE THE INK NEEDS TO GO. ACCORDING TO THE REPORTER, THE ISSUE OCCURRED DURING A STANDARD PROCEDURE FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED . THIS EVENT INCLUDES 3 REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 1YV). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 1ZV). REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 07V 20). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (NM-400U-0425 LOT 1ZV).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14427 SINGLE USE INJECTOR INJECTOR AND SHEATHSET FBK AOMORI OLYMPUS CO., LTD. NM-400U-0425 1ZV 04953170422577

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown