BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENHANCE

    MDR report key: 16113208 · Received January 6, 2023

    Report

    Report Number
    3007593944-2023-00001
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    December 18, 2022
    Report Date
    January 6, 2023
    Manufacturer
    ASENSUS SURGICAL, INC.
    Product Code
    NAY
    UDI-DI
    00815440021894
    PMA / PMN Number
    K171120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON AND THE COMPLAINANT REPORTED THAT THE ISSUE WAS NOT RELATED TO THE USE OF THE SENHANCE SYSTEM USED IN THE FIRST PROCEDURE PERFORMED BUT RATHER INDUCED BY ELECTROCAUTERY. THE ONLY ENERGY POWERED ASENSUS SURGICAL DEVICE USED WAS A MONOPOLAR L-HOOK ELECTRODE Ø 5 MM X 310 MM PN X0007177 LOT NUMBER 929721. A SERVICE HISTORY REVIEW ON THE SENHANCE SYSTEM AND A DEVICE HISTORY REVIEW ON THE MONOPOLAR HOOK WERE COMPLETED. NO SIMILAR OCCURRENCES OR ANOMALOUS FINDINGS WERE IDENTIFIED. AS REPORTED IN NOTES OF THE COMPLAINT DETAILS SECTION, THE SURGEON WAS DEEMED TO BE TOO CLOSE TO THE VESSELS. NO MALFUNCTION OF ANY DEVICE WAS REPORTED. ACCORDING TO THE SURGEON, IT COULD JUST AS EASILY HAVE OCCURRED DURING OPEN OR LAPAROSCOPIC SURGERY. DR. (B)(6), MEDICAL AFFAIRS AND PROFESSIONAL EDUCATION, COMMENTED THAT A GASTRIC PERFORATION ALONG THE GREATER CURVATURE IS A KNOWN COMPLICATION OF FUNDOPLICATION AS A RESULT OF THERMAL SPREAD TO GASTRIC TISSUE DURING SHORT GASTRIC VESSEL SEALING. REGARDLESS OF THE TYPE OF DEVICE USED TO SEAL THESE VESSELS, CARE MUST BE TAKEN BY THE OPERATOR TO NOT GET TOO CLOSE TO THE STOMACH DURING SEALING AND TO LIMIT THE DEPLOYMENT OF ENERGY TO SHORT BURSTS. THESE TYPES OF MANEUVERS CAN HELP TO LIMIT LATERAL THERMAL SPREAD AND DECREASE THE INCIDENCE OF PERFORATION. PERFORATIONS OF THE STOMACH IN THIS OPERATION ARE A KNOWN COMPLICATION WITH VARYING ETIOLOGIES. THERE IS NO REPORT OR INDICATION THAT ANY ASENSUS SURGICAL'S DEVICE FAILED TO MEET SPECIFICATIONS. AN HEALTH HAZARD EVALUATION (TRACKED AS (B)(4)) WAS INITIATED. AS THIS IS THE FIRST CASE WHERE A PERFORATION OF THE WRAP AFTER A FUNDOPLICATION OCCURRED, THE EVENT WILL BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    THE EVENT WAS MADE AWARE ON 12/19/2023. THE EVENT OCCURRED AT (B)(6). AS INITIALLY REPORTED BY THE COMPLAINANT, ON THURSDAY, (B)(6) 2022, DOCTOR VISSCHERS, PERFORMED A FUNDOPLICATION ON A PEDIATRIC FEMALE PATIENT. THE PATIENT WAS DOING WELL AND WAS DISCHARGED ON FRIDAY, (B)(6) 2022. NO CHANGE TO THE SURGICAL APPROACH OR ADDITIONAL PORTS WERE NEEDED. ON SUNDAY, (B)(6) 2022 THE PATIENT WAS READMITTED TO THE HOSPITAL WITH PERSISTENT ABDOMINAL PAIN, WHICH REQUIRED A SECOND OPERATION. THE SURGEONS DIAGNOSED A PERFORATION OF THE WRAP, SURROUNDING THE ESOPHAGUS, DEEMED TO BE RELATED TO A THERMAL LESION AFFECTING THE VASA PREVIA, NAMELY THE BRANCHES OF SPLENIC ARTERY AND VEIN THAT RUN TO THE GREATER CURVATURE OF THE STOMACH. THE PATIENT WAS THEREFORE TREATED WITH ANTIBIOTICS AND 2 DRAINS WERE APPLIED ON THE STOMACH AND SMALL PELVIS. SUBSEQUENT ECHOGRAPHY AND GASTROSCOPY REVEALED NO INDICATION OF A PERSISTENT PERFORATION. ON FRIDAY,(B)(6) 2022 THE PATIENT WAS DOING WELL AND WAS REPORTED TO BE LIVELY AND ACTIVE. THE SURGEON AND THE COMPLAINANT REPORTED THAT THE ISSUE WAS NOT RELATED TO THE USE OF THE SENHANCE SYSTEM USED IN THE FIRST PROCEDURE PERFORMED BUT RATHER INDUCED BY ELECTROCAUTERY. THE INSTRUMENTS THAT APPLY ENERGY USED DURING THE ROBOTIC ASSISTED FUNDOPLICATION WERE A MONOPOLAR L-HOOK ELECTRODE Ø 5 MM X 310 MM (X0007177) AND A BIPOLAR MARYLAND DISSECTOR Ø 5 MM X 310 MM (X0005149). THE SURGEON WAS DEEMED TO BE TOO CLOSE TO THE VESSELS. NO MALFUNCTION OF ANY DEVICE WAS REPORTED. ALSO ACCORDING TO THE INVESTIGATION, THERE IS NO INDICATION THAT ANY ASENSUS SURGICAL'S DEVICE FAILED TO MEET SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459625 SENHANCE MONOPOLAR L-HOOK ELECTRODE Ø 5 MM X 310 MM NAY ASENSUS SURGICAL, INC. X0007177 929721 00815440021894

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Required Intervention