BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRINCESS

    MDR report key: 10289878 · Received July 17, 2020

    Report

    Report Number
    1418479-2020-00015
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    June 24, 2020
    Report Date
    August 26, 2020
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FAS
    UDI-DI
    04055207048962
    PMA / PMN Number
    K062720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND/OR CHANGED INFORMATION. CHANGED INFORMATION: THE FOLLOWING FIELDS HAVE CHANGED INFORMATION: B4, B5, F1, F7, F13, G7, H3, H6, H7, H10. RWMIC COMPLETED ITS INVESTIGATION OF THE DEVICE. RWMIC RECEIVED AND VISUALLY EVALUATED THE DEVICE. THE REPORTED CONDITION WAS VERIFIED. THE PROBABLE ROOT CAUSE WAS ATTRIBUTED TO USER ERROR. THE DEVICE WAS SCRAPPED AND REPLACED. DEVICE LABELING WAS REVIEWED FOR PATIENT CODE AND DEVICE CODES, SEE BELOW: PATIENT CODE: NOT APPLICABLE, NO PATIENT PROBLEM WAS REPORTED. DEVICE CODE: IFU WAS REVIEWED IFU INCLUDES A CAUTION FOR COMBINING PRODUCTS: DO NOT COMBINE PRODUCTS INCORRECTLY! INJURIES OF THE PATIENT, USER OR OTHERS AS WELL AS DAMAGE TO THE PRODUCT ARE POSSI­BLE. THE DIFFERENT PRODUCTS MAY ONLY BE USED TOGETHER IF THEIR INTENDED USES AND THE RELEVANT TECHNICAL DATA (WORKING LENGTH, DIAMETER, PEAK VOLTAGE, ETC.) ARE THE SAME. IFU INCLUDES A WARNING FOR POSSIBLE DANGERS/RISK FACTORS: STRENGTH PROBLEMS; DAMAGE TO THE PRODUCT; SEVERE IMPAIRMENT OF THE FUNCTION; SUBSTANTIALLY INCREASED RISK OF INFECTION 'BIOCOMPATIBILITY PROBLEMS. IFU INCLUDES A CAUTION FOR LIMITED STRENGTH. "EXCESSIVE FORCE WILL CAUSE DAMAGE, IMPAIR THE FUNCTION, AND THEREFORE ENDANGER THE PATIENT. IMMEDIATELY BEFORE AND AFTER EACH USE, CHECK PRODUCTS FOR DAMAGE, LOOSE PARTS, AND COMPLETION. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE, OR HAVE LOOSE PARTS". THE IFU INCLUDES A "NOTE" ABOUT "EXCESSIVE POWER SETTINGS CAN CAUSE CLEARLY INCREASED ELECTRODE WEAR. WE RECOMMEND STARTING AT A LOWER POWER SETTING TO DETERMINE THE OPTIMUM POWER SETTING" RWMIC CONSIDERS THIS COMPLAINT AND MDR CLOSED. FOLLOW-UP REPORTS WILL BE SENT TO FDA AS REQUIRED. ATTACHMENT: [GA-D349 USA_6.0 (14-0506).PDF].

    Description of Event or Problem · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND/OR CHANGED INFORMATION. PLEASE REFER TO THE MANUFACTURERS NARRATIVE FOR DETAILS.

    Additional Manufacturer Narrative · 1

    USER FACILITY RETURNED THE DEVICE TO RW MIC ON 06/30/2020, AND CURRENTLY PENDING EVALUATION OF THE DEVICES. RW MIC WILL REACH OUT TO THE USER FACILITY AND THE MANUFACTURERS FOR ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY: DURING THE PROCEDURE THE CUTTING LOOPS TIP FRAYED AND MELTED. THERE WAS NO PATIENT INJURY AND THE CASE WAS COMPLETED. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752171 PRINCESS CUTTING ELECTRODE BIPOLAR SINGLE USE FAS RICHARD WOLF GMBH 46531313 4500277054 04055207048962

    Patients

    Seq Age Sex Outcome Treatment
    1