BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COREDX

    MDR report key: 11607493 · Received April 2, 2021

    Report

    Report Number
    3005099803-2021-01375
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 5, 2021
    Report Date
    April 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729971054
    PMA / PMN Number
    K183085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS EVENT PERTAINS TO ONE OF TWO COREDX BIOPSY FORCEPS USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO COREDX BIOPSY FORCEPS WERE USED IN THE TRANSBRONCHIAL TREE DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2021. THE BIOPSY FORCEPS WAS INSPECTED BEFORE THE PROCEDURE AND FOUND TO BE OKAY. HOWEVER, WHEN THE FORCEPS WAS WITHDRAWN OUT OF THE ENDOSCOPE AFTER OBTAINING THE SPECIMEN, THE NURSE FOUND NO SAMPLE IN THE JAWS. THE FORCEPS WAS TESTED AGAIN AND FOUND THE JAWS COULD NOT CLOSE. THE NURSE OPENED ANOTHER COREDX FORCEPS, BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN DECIDED NOT TO MAKE ANOTHER ATTEMPT AND STOPPED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506089 COREDX BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ BOSTON SCIENTIFIC CORPORATION M00515220 0026537762 08714729971054

    Patients

    Seq Age Sex Outcome Treatment
    1