BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTRTM TISSUE RESECTION DEVICE

    MDR report key: 9811008 · Received March 10, 2020

    Report

    Report Number
    3005099803-2020-00741
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    November 6, 2019
    Report Date
    March 10, 2020
    Manufacturer
    BIOMERICS LLC
    Product Code
    NWW
    UDI-DI
    08714729964537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 28, 2019 THAT A RESECTOR 5 FR WAS USED IN A POLYPECTOMY PROCEDURE IN THE UTERUS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, UPON STARTING TO SHAVE THE POLYP THE INTERNAL RESECTING BLADE BROKE OFF AND FELL INSIDE THE PATIENT. REPORTEDLY, IT WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276684 RESECTRTM TISSUE RESECTION DEVICE HYSTEROSCOPE ACCESSORIES NWW BIOMERICS LLC M0065907051 0009441380 08714729964537

    Patients

    Seq Age Sex Outcome Treatment
    1