BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COREDX

    MDR report key: 19839248 · Received July 26, 2024

    Report

    Report Number
    3005099803-2024-03568
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 3, 2024
    Report Date
    August 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729971054
    PMA / PMN Number
    K183085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS DIFFERENT TO OPEN OR CLOSE.

    Additional Manufacturer Narrative · 0

    BLOCK B5: UPDATED EVENT DESCRIPTION. BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS DIFFERENT TO OPEN OR CLOSE.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COREDX BIOPSY FORCEPS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, TWO FORCEPS WERE STUCK IN OPEN POSITION AND WERE UNABLE TO CLOSE WITH THE HANDLE. THE FIRST BIOPSY FORCEPS FAILED TO CLOSE AFTER FIRST SAMPLE AND THE SECOND FORCEPS FAILED TO CLOSE AFTER FOUR SAMPLE ATTEMPTS. NO FURTHER INFORMATION OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COREDX BIOPSY FORCEPS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COREDX BIOPSY FORCEPS WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS STUCK IN OPEN POSITION AND UNABLE TO CLOSE WITH THE HANDLE. THE FIRST BIOPSY FORCEPS FAILED TO CLOSE AFTER FIRST SAMPLE AND THE SECOND ONE FAILED TO CLOSE AFTER FOUR SAMPLE ATTEMPT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INFORMATION RECEIVED ON JULY 26, 2024. INFORMATION WAS RECEIVED THAT THIS EVENT IS A DUPLICATE. SEE MFR. REPORT #3005099803-2024-03023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914160 COREDX BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00515220 0032353641 08714729971054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown