BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENHANCE

    MDR report key: 17774469 · Received September 19, 2023

    Report

    Report Number
    3007593944-2023-00005
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    October 16, 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
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLAINT DETAILS (B)(4). THERE WAS A REPORT OF AN ADVERSE EVENT TO A PATIENT. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT (B)(6) HOSPITAL IN AUSTRIA. THIS EVENT OCCURRED ON (B)(6) 2020 AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 07-SEPT-2022. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM THE SURGEON THAT THE EVENT WAS UNRELATED TO THE SENHANCE SYSTEM BUT RATHER A NORMAL SURGICAL COMPLICATION. FURTHERMORE, NO MALFUNCTION OF THE SENHANCE SYSTEM WAS REPORTED. NO FAILURES WERE IDENTIFIED. THE RISK POSED BY THIS EVENT WAS EVALUATED THOUGH HHE-001-00027 LINKED IN THE RISK PROFILE ASSESSMENT SECTION BELOW 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. THE INVESTIGATION, CONFIRMED BY SURGEON INTERVIEWS, FOUND THERE WAS NO MALFUNCTION OF THE ROBOT AND NO FAILURES IDENTIFIED, THEREFORE ASENSUS REPORTS THIS EVENT FOR COMPLETENESS TO THE INITIAL MDR REPORT SUBMITTED ON 19-SEPTEMBER-2023.

    Description of Event or Problem · 0

    THE COMPLAINANT, DR. (B)(6), REPORTED A PATIENT BLADDER RUPTURE FOR WHICH SURGICAL INTERVENTION WAS NEEDED. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE, BUT WITHOUT ANY FURTHER DETAILS PERTAINING TO PATIENT TREATMENT OR RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN FELDKIRCH REGIONAL HOSPITAL IN AUSTRIA. ADDITIONALLY, THIS EVENT OCCURRED ON 16-OCTOBER-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 07-SEPTEMBER-2022.

    Description of Event or Problem · 0

    THE COMPLAINANT, DR. (B)(6), REPORTED A PATIENT BLADDER RUPTURE FOR WHICH SURGICAL INTERVENTION WAS NEEDED. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE, BUT WITHOUT ANY FURTHER DETAILS PERTAINING TO PATIENT TREATMENT OR RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6) HOSPITAL IN AUSTRIA. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447176 SENHANCE SENHANCE SURGICAL SYSTEM NAY ASENSUS SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention