BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENHANCE

    MDR report key: 17774532 · Received September 19, 2023

    Report

    Report Number
    3007593944-2023-00007
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    May 28, 2022
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLAINT DETAILS ((B)(4)), THE PATIENT EXPERIENCED NARROW STENOSIS IN THE GASTRO-ESOPHAGEAL AREA AND ASSOCIATED VOMITING FOR WHICH PATIENT WAS TREATED WITH ANTIEMETICS (DOMPERIDONE; TOTAL DOSAGE ADMINISTRATED: 50,00 MG) AND PERFORMED AN OGD (OESOPHAGOGASTRODUODENOSCOPY) WITH DILATATION FOR (B)(6) 2022 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT (B)(6) IN GERMANY. THE EVENT OCCURRED ON 28-MAY-2022, AND ASENSUS SURGICAL WAS MADE AWARE ON 29-JUNE-2022. ACCORDING TO THE INVESTIGATION, FURTHER INTERVIEW QUESTIONS POSED TO THE SURGEON CONFIRM THAT PATIENT ID (B)(6) BELONGED TO A MALE PATIENT WITH AN INGUINAL HERNIA, WITHOUT SURGICAL PROBLEMS. THE CORRECTED PATIENT CREDENTIALS FOR THIS PARTICULAR EVENT IS A FEMALE PATIENT WITH ID (B)(6) AND WAS FOUND TO ALREADY BE HANDLED IN A SEPARATE (B)(4) FOR THE SERIOUS ADVERSE EVENT ASSOCIATED WITH VERIFIED FEMALE PATIENT ID (B)(6). THEREFORE, AS NO SERIOUS ADVERSE EVENT OCCURRED ON THE MALE PATIENT ID (B)(6), THIS COMPLAINT IS DEEMED ERRONEOUS. ASENSUS SURGICAL IS REPORTING THIS FOLLOWUP WITH THE CORRECTED PATIENT DATA TO UPDATE THE INITIAL MDR REPORT SUBMITTED ON 19-SEPTEMBER-2023.

    Description of Event or Problem · 0

    THE COMPLAINANT, (B)(6), REPORTED THAT A PATIENT EXPERIENCED NARROW STENOSIS IN THE GASTRO-ESOPHAGEAL AREA AND VOMITING FOR WHICH TREATMENT WITH ANTIEMETICS WAS ADMINISTRATED (DOMPERIDONE-50,00 MG TOTAL DOSAGE); ADDITIONALLY, AN OGD + DILATATION WAS PERFORMED FOR A (B)(6) 2022 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 29-JUNE-2022.

    Description of Event or Problem · 0

    THE COMPLAINANT, BETTINA PFEIFFER, REPORTED THAT A PATIENT EXPERIENCED NARROW STENOSIS IN THE GASTRO-ESOPHAGEAL AREA AND AND VOMITING FOR WHICH TREATMENT WITH ANTIEMETICS WAS ADMINISTRATED (DOMPERIDONE-50,00 MG TOTAL DOSAGE); ADDITIONALLY, AN OGD + DILATATION WAS PERFORMED FOR (B)(6) 2022 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6) IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON 28-MAY-2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 29-JUNE-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817939 SENHANCE SENHANCE SURGICAL SYSTEM NAY ASENSUS SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R