BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESECTRTM TISSUE RESECTION DEVICE

    MDR report key: 7133052 · Received December 20, 2017

    Report

    Report Number
    3005099803-2017-03803
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 6, 2017
    Report Date
    December 6, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    NWW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER COULD NOT BE MATCHED TO THE REPORTED DEVICE. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME. MANUFACTURER: (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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2017 THAT A RESECTR 5FR DEVICE WAS INTENDED TO BE USED ON AN OPERATIVE HYSTEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A HAIR WAS NOTICED LODGED ON THE DEVICE'S SPRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESECTR DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911908 RESECTRTM TISSUE RESECTION DEVICE HYSTEROSCOPE ACCESSORIES NWW BOSTON SCIENTIFIC - MARLBOROUGH M0065907051

    Patients

    Seq Age Sex Outcome Treatment
    1