BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS PLASMASORD (5/PK)

    MDR report key: 5551134 · Received April 6, 2016

    Report

    Report Number
    3011050570-2016-00003
    Event Type
    Injury
    Date Received
    April 6, 2016
    Date of Event
    January 11, 2016
    Report Date
    February 8, 2021
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    GEI
    PMA / PMN Number
    K080093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED PER FDA REQUEST AFTER INITIAL FAILURE. THE INFORMATION HERE WITH-IN IS REFLECTIVE OF THE ORIGINAL DATA SUBMITTED IN THE INITIAL REPORT ON 04APR2016. AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    PERFORMANCE REPORT, NO DEVICE IS BEING RETURNED FOR EVALUATION. THIS DEVICE WAS USED DURING AN OVARIAN CYSTECTOMY. NO STAFF FROM OIB WAS PRESENT AT THE SURGERY, BUT THE CUSTOMER CLAIMS THE NURSE STAFF OBSERVED AN INVOLUNTARY MOVEMENT OF THE LEFT LEG OF THE PATIENT WHEN MORCELLATING THE CYST DUE TO, ACCORDING TO THE DOCTOR, A POSSIBLE ELECTRICAL LEAKAGE OF THE BIPOLAR DEVICE. THE MORCELLATOR COULDN'T BE RETRIEVED AND WE HAVE NO RECORDINGS OF THE SURGERY TO PROVIDE ANY EVIDENCE OF THESE CIRCUMSTANCES. THE PK MORCELLATOR WAS PLUGGED TO GENERATOR G400 SERIAL NO: (B)(4). REMOVAL OF A SOLID 7CM DIAMETER OVARIAN CYST. MORCELLATING THE CYST, THERAPEUTIC. THE PARALISIS WAS DETECTED AFTER FINISHING THE SURGERY (ALTHOUGH SOME STAFF OR NURSES DETECTED AN ABNORMAL INVOLUNTARY MOVEMENT OF THE PATIENT'S LEG DURING THE SURGERY). FEMORAL NERVE PARALYSIS. THE PATIENT IS PROGRESSIVELY RECOVERING FROM THIS PARALYSIS DUE TO REHAB THERAPY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208904 PKS PLASMASORD (5/PK) PLASMASORD GEI OLYMPUS SURGICAL TECHNOLOGIES AMERICA 962000PK U1508092

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| S