BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COREDX

    MDR report key: 19838194 · Received July 26, 2024

    Report

    Report Number
    3005099803-2024-03567
    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 B5: UPDATED EVENT DESCRIPTION. BLOCK H2: CORRECTION: INFORMATION RECEIVED ON JULY 26, 2024, THAT THIS REPORT IS A DUPLICATE SENT IN ERROR. PLEASE REFER TO MFR. REPORT #3005099803-2024-03020. BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS DIFFICULT TO OPEN OR CLOSE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO THE SECOND 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. ***INFORMATION RECEIVED ON JULY 26, 2024*** INFORMATION WAS RECEIVED THAT THIS EVENT IS A DUPLICATE. SEE MFR. REPORT #3005099803-2024-03020.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO THE SECOND 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922579 COREDX BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00515220 0032353641 08714729971054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown