BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETOME JAG 44

    MDR report key: 19706531 · Received July 9, 2024

    Report

    Report Number
    3005099803-2024-03258
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729858645
    PMA / PMN Number
    K122203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A020504 CAPTURES THE REPORTABLE EVENT OF A HOLE IN THE DEVICE PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 WAS UNPACKED BY THE DISTRIBUTOR ON (B)(6) 2024. IT WAS REPORTED THAT UPON UNPACKING THE DEVICE FROM THE SHIPPING CONTAINER, THERE WAS A HOLE ON THE STERILE POUCH OF THE DEVICE PACKAGING. THE PRODUCT WAS NOT USED IN A PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271618 TRUETOME JAG 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00583100 0033752440 08714729858645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown