BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUCISE RP 35, ACU-PACK

    MDR report key: 314817 · Received February 1, 2001

    Report

    Report Number
    2027111-2001-00005
    Event Type
    Other
    Date Received
    February 1, 2001
    Date of Event
    November 28, 2000
    Report Date
    February 1, 2001
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOPYELOTOMY PROCEDURE THAT THE B1005 ACUCISE CATHETER CUTTING WIRE BROKE AFTER ACTIVATION. THE SURGEON HAD DIFFICULTY REMOVING THE CATHETER. NO PT INJURY OR COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4022 ACUCISE RP 35, ACU-PACK ACUCISE CATHETER KOD APPLIED MEDICAL RESOURCES B1005 00D367

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other