BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACURETTE CURVED 8MM 10/PKG

    MDR report key: 9786213 · Received March 4, 2020

    Report

    Report Number
    2951238-2020-00352
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    January 13, 2020
    Report Date
    December 10, 2020
    Manufacturer
    BERKELEY MEDEVICES
    Product Code
    HHI
    PMA / PMN Number
    K030935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE LEGAL MANUFACTURER FOR MDR# 2951238-2020-00352. NO DEVICE WAS RETURNED; THEREFORE, A PHYSICAL EVALUATION OF THE COULD NOT BE PERFORMED. ADDITIONALLY, THE DEVICE HISTORY RECORDS COULD NOT BE OBTAINED BY THE ORIGINAL EQUIPMENT MANUFACTURER. AN INVESTIGATION WAS COMPLETED BY THE LEGAL MANUFACTURER, HOWEVER, BASED ON LIMITED INFORMATION A ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE SERVICE CENTER FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. UPON RETURN OF THE DEVICE, AN EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SERVICE CENTER RECEIVED A USER MEDWATCH REPORTING A TIP OF A VACURETTE CANNULA THAT WAS BROKEN OFF AND MISSING. THE NURSE OBSERVED THE BROKEN CURETTE AFTER COMPLETION OF A THERAPEUTIC DILATION AND CURETTAGE FOR A DELAYED MISCARRIAGE. THE PACKAGING WHICH CONTAINED THE DEVICE WAS INSPECTED AND BROKEN ITEMS OF THE VACURETTE CANNULA WAS OBSERVED. THE SURGEON WAS NOTIFIED AND A UTERINE ULTRASOUND OF THE PATIENT WAS PERFORMED TO LOOK FOR ANY DEVICE FRAGMENTS. NONE WERE REPORTED TO BE FOUND. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248207 VACURETTE CURVED 8MM 10/PKG VACUUM CURETTAGE SYSTEM HHI BERKELEY MEDEVICES 20317 02194485

    Patients

    Seq Age Sex Outcome Treatment
    1