BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOTOR POWER PLUS CONTROL UNIT

    MDR report key: 8341082 · Received February 14, 2019

    Report

    Report Number
    1418479-2019-00006
    Event Type
    Death
    Date Received
    February 14, 2019
    Date of Event
    December 17, 2012
    Report Date
    January 20, 2016
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HET
    PMA / PMN Number
    K080365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING WAS REVIEWED FOR PATIENT CODE AND DEVICE CODES: RELATIVE OR ABSOLUTE CONTRAINDICATIONS MAY RESULT FROM THE GENERAL MEDICAL FINDINGS OR IN SPECIAL CASES IN WHICH THE PATIENT'S RISK FOR MOTOR-DRIVEN TOOLS IS SIGNIFICANTLY INCREASED. OVARIES, FALLOPIAN TUBES, MYOMATA AND OTHER STRUCTURES MUST BE DEVASCULARIZED AND DISSECTED BEFORE MORCELLATION. THE MORCELLATOR MAY NOT BE USED FOR: TREATMENT OF MALIGNANT TUMOURS, TREATMENT OF VASCULARIZED TISSUE, PREPARATION OF TISSUE. CASES DESCRIBED IN THE RELEVANT LITERATURE MUST BE TAKEN INTO ACCOUNT. AS A MATTER OF PRINCIPLE: THE MORCE POWER PLUS MAY ONLY BE OPERATED BY COMPETENT TRAINED PERSONNEL! THE PHYSICIAN SHOULD READ THIS ENTIRE MANUAL WITH PARTICULAR ATTENTION TO THE WARNINGS, CAUTIONS AND PRECAUTIONS SECTION AND BE THOROUGHLY FAMILIAR WITH THE USE OF THE INSTRUMENT PRIOR TO PERFORMING ANY CLINICAL PROCEDURE! PROCEDURES PERFORMED USING THE MORCE POWER PLUS, AS WITH ANY ENDOSCOPIC INSTRUMENT REQUIRE ADEQUATE KNOWLEDGE, TRAINING AND PREPARATION ON THE PART OF THE PHYSICIAN/SURGEON! THE USE OF THIRD-PARTY PRODUCTS IS THE RESPONSIBILITY OF THE OPERATOR! REPAIRS ARE TO BE CARRIED OUT BY AUTHORISED RICHARD-WOLF SERVICE TECHNICIANS EXCLUSIVELY! FAILURE TO CAREFULLY FOLLOW ALL APPLICABLE INSTRUCTIONS MAY RESULT IN SIGNIFICANT INJURY TO THE PATIENT, PHYSICIAN, OR ATTENDANTS AND HAVE AN ADVERSE EFFECT ON THE OUTCOME OF PROCEDURES PERFORMED! IMPROPER USE AND REPAIR OF THE DEVICE, AS WELL AS FAILURE TO COMPLY WITH OUR INSTRUCTIONS ABSOLVES US FROM ANY PERFORMANCE GUARANTEE OR OTHER CLAIMS! THE USE OF A TISSUE EXTRACTION BAG IS RECOMMENDED FOR THE MORCELLATION OF TISSUE SUSPECTED OF BEING MALIGNANT AND FOR TISSUE THE SURGEON MAY CONSIDER TO BE POTENTIALLY HARMFUL WHEN DISSEMINATED IN THE BODY CAVITY. RWMIC CONSIDERS THIS COMPLAINT AND MDR CLOSED. IF ANY ADDITIONAL INFORMATION IS PROVIDED, RWMIC WILL PROVIDE A FOLLOW-UP REPORT AS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS NOTIFIED BY OUR ATTORNEY OF A LAWSUIT FILED ON BEHALF OF THE DECEASED PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2012, THE PATIENT UNDERWENT A SURGICAL PROCEDURE KNOWN AS A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND LEFT SALPINGO-OOPHORECTOMY. DURING THAT PROCEDURE, THE SURGEON UTILIZED THE POWER MORCELLATOR DEVICE TO SHRED OR MORCELLATE AND REMOVE THE PATIENT'S UTERUS. AFTER THE SURGERY, A PATHOLOGY REPORT SHOWED LEIOMYOSARCOMA IN THE MORCELLATED TISSUE. IT IS ALLEGED THAT THE MORCELLATION SURGERY SEEDED OR UPSTAGED THE PATIENT'S CANCER. THE PATIENT WENT THROUGH CHEMOTHERAPY AND RADIATION TREATMENT, AS WELL AS ADDITIONAL SURGERY TREATMENT. THE PATIENT DIED ON (B)(6) 2013. LABELING AND DESIGN FLAWS ARE MENTIONED IN THE LAWSUIT AND THEREFORE, REFERENCED IN EVENT PROBLEM AND EVALUATION CODES. THE DEVICE LISTED WAS THE MORCE POWER PLUS MORCELLATOR. PART AND BATCH NUMBER INFORMATION WAS NOT PROVIDED AND THE DEVICE WAS NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131740 MOTOR POWER PLUS CONTROL UNIT MOTOR POWER PLUS CONTROL UNIT HET RICHARD WOLF GMBH 2307101

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R