BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENHANCE

    MDR report key: 17774367 · Received September 19, 2023

    Report

    Report Number
    3007593944-2023-00008
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    February 29, 2020
    Report Date
    October 12, 2023
    Manufacturer
    ASENSUS SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K171120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLAINT DETAILS (PCR-001555), THE PATIENT EXPERIENCED ANASTOMOTIC LEAKAGE WITH SYMPTOMS OF FEVER AND SIGNS OF PERITONITIS. THE PATIENT WAS RE-OPERATED WITH A LAPAROTOMY. AFTER A LONG POSTOPERATIVE COURSE, THE PATIENT RECOVERED AND WAS DISCHARGED. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT KLAIPEDA UNIVERSITY HOSPITAL IN LITHUANIA. THE EVENT OCCURRED ON 29-FEBRUARY-2020 (WAS RESOLVED ON 20-MARCH-2020), AND ASENSUS SURGICAL WAS MADE AWARE ON 16-AUGUST-2023. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM THE SURGEON INTERVIEWS INDICATED THAT THE ANASTOMOTIC LEAKAGE EVENT WAS NOT RELATED TO THE SENHANCE SURGICAL SYSTEM, BUT RATHER CONSIDERED TO BE A NORMAL SURGICAL COMPLICATION UNRELATED TO THE ROBOT. FURTHERMORE, NO MALFUNCTION OF THE SENHANCE SYSTEM WAS REPORTED AND NO FAILURES WERE IDENTIFIED. THE RISK POSED BY THIS EVENT WAS EVALUATED THROUGH A HEALTH HAZARD EVALUATION (HHE-001-00025) AND A CORRECTIVE ACTION PREVENTATIVE ACTION PLAN (CAPA-000048) HAS BEEN OPENED TO MANAGE THE UNSUITABLE TIMELINESS OF THE RECEIPT AND MANAGEMENT OF THIS REPORTED EVENT. THEREFORE, ASENSUS SURGICAL IS REPORTING THIS FOLLOWUP FOR COMPLETENESS TO THE INITIAL MDR REPORT SUBMITTED ON 18-SEPTEMBER-2023.

    Description of Event or Problem · 0

    THE COMPLAINANT, VAIDA NAUSEDIENE, REPORTED THAT ON DAY 4, THE PATIENT DEVELOPED FEVER, SIGNS OF PERITONITIS. THE ADVERSE EVENT WAS AN ANASTOMOTIC LEAKAGE. ON (B)(6) 2020, PATIENT WAS RE-OPERATED VIA LAPAROTOMY, DISRUPTION OF ANASTOMOSIS, LAVAGE AND DRAINAGE OF THE ABDOMEN, END COLOSTOMY. PATIENT WAS THEN TREATED IN ICU, THUS POSTOPERATIVE COURSE AND RECOVERY WAS LONGER DUE TO INFECTION OF THE LAPAROTOMY WOUND, WITH OBESITY AND CO-MORBIDITIES PRESENT. PATIENT RECOVERED AND WAS DISCHARGED FOR A 20-MARCH-2020 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THE EVENT OCCURRED IN (B)(6) HOSPITAL IN LITHUANIA. ADDITIONALLY, THIS EVENT OCCURRED ON 29-FEBRUARY-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 16-AUGUST-2023.

    Description of Event or Problem · 0

    THE COMPLAINANT, VAIDA NAUSEDIENE, REPORTED THAT ON DAY 4, THE PATIENT DEVELOPED FEVER, SIGNS OF PERITONITIS. THE ADVERSE EVENT WAS AN ANASTOMOTIC LEAKAGE. ON (B)(6) 2020, PATIENT WAS RE-OPERATED VIA LAPAROTOMY, DISRUPTION OF ANASTOMOSIS, LAVAGE AND DRAINAGE OF THE ABDOMEN, END COLOSTOMY. PATIENT WAS THEN TREATED IN ICU, THUS POSTOPERATIVE COURSE AND RECOVERY WAS LONGER DUE TO INFECTION OF THE LAPAROTOMY WOUND, WITH OBESITY AND CO-MORBIDITIES PRESENT. PATIENT RECOVERED AND WAS DISCHARGED FOR A (B)(6) 2020 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THE EVENT OCCURRED IN (B)(6). ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062953 SENHANCE SENHANCE SUGICAL SYSTEM NAY ASENSUS SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R