BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE BICLAMP LAPAROSCOPIC INSERT

    MDR report key: 15391418 · Received September 9, 2022

    Report

    Report Number
    9610614-2022-00031
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    August 18, 2021
    Report Date
    September 9, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K033421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BICLAMP LAPAROSCOPIC INSERT WAS NOT PROVIDED FOR AN EVALUATION (NOTE: ALSO, NONE OF OTHER INVOLVED EQUIPMENT/ACCESSORIES WERE MADE AVAILABLE FOR AN ASSESSMENT.). DUE TO THE LACK OF INFORMATION, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. HOWEVER, MOST LIKELY THE INADVERTENT ACTIVATION OF THE BICLAMP LAPAROSCOPIC INSERT WAS A SIGNIFICANT FACTOR IN THE EVENT. NO TRENDS HAVE BEEN IDENTIFIED. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE BICLAMP LAPAROSCOPIC INSERT DURING A HYSTERECTOMY/BILATERAL ADNEXECTOMY AND PELVIC LYMPH NODE DISSECTION FOR A MALIGNANT UTERINE TUMOR. THE ACCESSORY WAS BEING USED WITH AN ELECTROSURGICAL UNIT (ESU). SPECIFIC INFORMATION REGARDING THE ESU, SETTINGS, AND OTHER DEVICES USED WAS NOT PROVIDED. DURING THE PROCEDURE, THERE WAS TISSUE DAMAGE OR INJURY TO THE UTERINE ARTERY. A SUTURE WAS THEN USED TO ESTABLISHED HEMOSTASIS. ADDITIONALLY, IT WAS CONVEYED THAT THERE WAS AN UNINTENTIONAL ACTIVATION OF THE INSTRUMENT. AT THE END OF AUGUST 2021, THE PATIENT DEVELOPED "URINARY LEAKAGE" AND WAS TRANSFERRED TO NEIJIANG SECOND PEOPLE'S HOSPITAL FOR TREATMENT WITH A DIAGNOSIS OF URETERAL INJURY CAUSED BY THE PRIMARY SURGERY. NO FURTHER INFORMATION WAS PROVIDED IN REGARDS TO ANY ADDITIONAL TREATMENT OR THE PATIENT'S MEDICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819660 ERBE BICLAMP LAPAROSCOPIC INSERT BIPOLAR ESU LAPAROSCOPIC INSTRUMENT GEI ERBE ELEKTROMEDIZIN GMBH 989430

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention| H