BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENHANCE

    MDR report key: 17774611 · Received September 19, 2023

    Report

    Report Number
    3007593944-2023-00006
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    October 21, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLAINT DETAILS ( (B)(4) ), THE PATIENT EXPERIENCED A SUTURE FAILURE WHICH REQUIRED AN INTERVENTION OF TREATMENT WITH A SECOND LAPAROSCOPY, COLONOSCOPY, AND ENDOVAC THERAPY. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THIS EVENT OCCURRED AT EVANGELISCHES KRANKENHAUS WESEL IN GERMANY. THE EVENT OCCURRED ON 21-OCTOBER-2022, AND ASENSUS SURGICAL WAS MADE AWARE ON 09-MARCH-2023. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM SURGEON INTERVIEWS INDICATED THAT THE SUTURE FAILURE EVENT THAT OCCURRED WAS NOT RELATED TO THE SENHANCE SURGICAL SYSTEM AND POSSIBLY WITH THE STAPLER-ANASTOMOSIS. 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-001-00035) 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 OCCURRED OUTSIDE THE UNITED STATES. THE EVENT OCCURRED ON (B)(6) 2022, INTERNALLY MADE AWARE ON (B)(6) 2023. THE PATIENT EXPERIENCED SUTURE FAILURE WHICH REQUIRED INTERVENTION FOR TREATMENT (RESOLVED ON (B)(6) 2022). INTERVENTION INCLUDED, RELAPAROSCOPY, COLONOSCOPY, AND ENDOVAC THERAPY. IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE.

    Description of Event or Problem · 0

    THE EVENT OCCURRED OUTSIDE THE UNITED STATES. THE EVENT OCCURRED ON 10/21/2022, INTERNALLY MADE AWARE ON 3/9/2023. THE PATIENT EXPERIENCED SUTURE FAILURE WHICH REQUIRED INTERVENTION FOR TREATMENT (RESOLVED ON (B)(6) 2022). INTERVENTION INCLUDED, RELAPAROSCOPY, COLONOSCOPY, AND ENDOVAC THERAPY. IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061324 SENHANCE SENHANCE SURGICAL SYSTEM NAY ASENSUS SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention