BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENHANCE

    MDR report key: 17774536 · Received September 19, 2023

    Report

    Report Number
    3007593944-2023-00015
    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 FEMALE 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 A (B)(6) 2022 DATE OF RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT EVANGELISCHES KRANKENHAUS WESEL IN GERMANY. THE EVENT OCCURRED ON 28-MAY-2022, AND ASENSUS SURGICAL WAS MADE AWARE ON 04-JULY-2022. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM SURGEON INTERVIEWS INDICATED THAT THE ADVERSE 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-001-00031) 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 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 EVANGELISCHES KRANKENHAUS WESEL GMBH IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON 28-MAY-2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 04-JULY-2022.

    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) IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585336 SENHANCE SENHANCE SURGICAL SYSTEM NAY ASENSUS SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention