BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENHANCE

    MDR report key: 17774502 · Received September 19, 2023

    Report

    Report Number
    3007593944-2023-00004
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    October 20, 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 ((B)(4)), THE PATIENT EXPERIENCED ANASTOMOTIC LEAKAGE, WAS SUCCESSFULLY TREATED WITH ANTIBIOTICS (METRONIDAZOLE 500MG 3X DAILY, CEFUROXIME 1G 3X DAILY), AND HAD A PROLONGED HOSPITAL STAY BUT RECOVERED FOR A 04-NOVEMBER-2020 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT (B)(6) HOSPITAL IN LITHUANIA. THE EVENT OCCURRED ON 20-OCTOBER-2020, AND ASENSUS SURGICAL WAS MADE AWARE ON 10-AUGUST-2023. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM 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 (B)(4) 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 19-SEPTEMBER-2023.

    Description of Event or Problem · 0

    THE COMPLAINANT, (B)(6), REPORTED THAT ON DAY 6, THERE WAS AN ANASTOMOTIC LEAKAGE DETECTED, THEN CLINICALLY AND DIGITALLY CONFIRMED. PATIENT WAS ADMINISTERED ANTIBIOTIC THERAPY (METRONIDAZOLE-500 MG 3X DAILY; CEFUROXIME-1 G 3X DAILY) AND HAD A PROLONGED HOSPITAL STAY BUT RECOVERED FOR A (B)(6) 2020 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THIS EVENT OCCURRED IN (B)(6) HOSPITAL IN LITHUANIA. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 10-AUGUST-2023.

    Description of Event or Problem · 0

    THE COMPLAINANT, (B)(6), REPORTED THAT ON DAY 6, THERE WAS AN ANASTOMOTIC LEAKAGE DETECTED, THEN CLINICALLY AND DIGITALLY CONFIRMED. PATIENT WAS ADMINISTERED ANTIBIOTIC THERAPY (METRONIDAZOLE-500 MG 3X DAILY; CEFUROXIME-1 G 3X DAILY) AND HAD A PROLONGED HOSPITAL STAY BUT RECOVERED FOR A 04-NOVEMBER-2020 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THIS EVENT OCCURRED IN (B)(6) HOSPITAL IN LITHUANIA. ADDITIONALLY, THIS EVENT OCCURRED ON 20-OCTOBER-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 10-AUGUST-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596257 SENHANCE SENHANCE SURGICAL SYSTEM NAY ASENSUS SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R