BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EURO-MED

    MDR report key: 1468951 · Received September 4, 2009

    Report

    Report Number
    1216677-2009-00024
    Event Type
    Injury
    Date Received
    September 4, 2009
    Date of Event
    August 26, 2009
    Report Date
    September 3, 2009
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO TIPS WERE RETURNED BY THE USER FACILITY. THE TIPS ARE ALLEGED TO NOT CLOSE COMPLETELY. THE TIPS WERE INSERTED INTO A HANDLE AND WERE FOUND TO FUNCTION AS DESIGNED. BIOPSY TIPS AND HANDLES ARE NOT SOLD IN MATCHED SETS, THEREFORE ON OCCASION, NEWER TIPS DO NOT FUNCTION AS DESIRED IN OLDER HANDLES. THE TIP'S POWER CAN BE ADJUSTED TO FUNCTION CORRECTLY IN A HANDLE.

    Description of Event or Problem · 1

    DURING A COLPOSCOPY PROCEDURE, THE PHYSICIAN PERFORMED A BIOPSY. THE PT EXPERIENCED EXCESSIVE BLEEDING. MONSEL'S AND SILVER NITRATE WERE USED TO STOP THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EURO-MED ROTATING BIOPSY TIP KNW COOPERSURGICAL, INC. 64-751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention