BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENHANCE

    MDR report key: 17774540 · Received September 19, 2023

    Report

    Report Number
    3007593944-2023-00002
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    February 24, 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
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLAINT DETAILS (B)(4). THE PATIENT EXPERIENCED A RECTAL PERFORATION REQUIRING A SURGERY. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT (B)(6) IN AUSTRIA. THE EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS MADE AWARE ON 06-SEPTEMBER-2022. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM SURGEON INTERVIEWS INDICATED THAT THE RECTAL PERFORATION THAT OCCURRED 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-001-00030) 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 EVENT OCCURED IN (B)(6) HOSPITAL IN AUSTRIA. THE EVENT OCCURED ON 2/24/2022, AND INTERNALLY MADE AWARE ON 9/6/2022. THE PATIENT EXPERIENCED RECTAL PERFORATION WHICH WAS TREATED (RESOLVED ON (B)(6) 2022). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE.

    Description of Event or Problem · 0

    THE EVENT OCCURED IN (B)(6) HOSPITAL IN AUSTRIA. THE EVENT OCCURED ON (B)(6) 2022, AND INTERNALLY MADE AWARE ON 9/6/2022. THE PATIENT EXPERIENCED RECTAL PERFORATION WHICH WAS TREATED (RESOLVED IN (B)(6) 2022). IT WAS REPORTED THAT THE CAUSALITY TO THE ENHANCE SURGICAL SYSTEM WAS PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585340 SENHANCE SENHANCE SURGICAL SYSTEM NAY ASENSUS SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention