BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENHANCE

    MDR report key: 17774590 · Received September 19, 2023

    Report

    Report Number
    3007593944-2023-00009
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    September 5, 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, THERE WAS A REPORT OF AN ADVERSE EVENT TO A PATIENT. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THIS EVENT OCCURRED AT (B)(6). THE EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 02-DEC-2022. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM THE SURGEON CONFIRMED THAT THE PROBLEM WAS ASSOCIATED WITH THE MEDICAL HISTORY OF THE PATIENT AND NOT RELATED THE SENHANCE SURGICAL SYSTEM. NO CAUSALITY WITH THE SENHANCE SURGICAL SYSTEM WAS IDENTIFIED. FURTHERMORE, NO MALFUNCTION OF THE SENHANCE SYSTEM WAS REPORTED. NO FAILURES WERE IDENTIFIED. THE RISK POSED BY THIS EVENT WAS EVALUATED THOUGH HHE-001-00034 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.

    Description of Event or Problem · 0

    THE COMPLAINANT, DR. (B)(6) REPORTED THAT ON (B)(6) 2022, A GASTROSCOPY WAS PERFORMED FOR DYSPHAGIA. THIS EVENT REVEALED A BOLUS OCCLUSION IN THE LOWER ESOPHAGUS WITH NECROSIS OF THE WALL TO INDICATE AN ESOPHAGEAL PERFORATION. THE PATIENT WAS TREATED VIA RE-LAPAROSCOPY, ESOPHAGEAL SUTURE, ESOSPONGE, AND SEVERAL VAC CHANGES. VAC THERAPY WAS COMPLETED ON (B)(6) 2022 ON (B)(6) 2022, AN X-RAY SWALLOW SHOWED TIGHTNESS AND AFTER A SLOW BUILD-UP OF FOOD, THE PATIENT WAS DISCHARGED ON (B)(6) 2022. AT HOME THE PATIENT WAS LISTLESS AND WAS RE-ADMITTED AS INPATIENT FROM (B)(6) 2022 THRU (B)(6) 2022 WHEN SHE WAS DISCHARGED. AFTER THIS PERIOD, PATIENT DID WELL WITH NO WEIGHT LOSS AND NO DYSPHAGIA. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS CERTAIN. 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 02-DECEMBER- 2022.

    Description of Event or Problem · 0

    THE COMPLAINANT, DR. (B)(6), REPORTED THAT ON (B)(6) 2022, A GASTROSCOPY WAS PERFORMED FOR DYSPHAGIA. THIS EVENT REVEALED A BOLUS OCCLUSION IN THE LOWER ESOPHAGUS WITH NECROSIS OF THE WALL TO INDICATE AN ESOPHAGEAL PERFORATION. THE PATIENT WAS TREATED VIA RE-LAPAROSCOPY, ESOPHAGEAL SUTURE, ESOSPONGE, AND SEVERAL VAC CHANGES. VAC THERAPY WAS COMPLETED ON (B)(6) 2022. ON (B)(6) 2022, AN X-RAY SWALLOW SHOWED TIGHTNESS AND AFTER A SLOW BUILD-UP OF FOOD, THE PATIENT WAS DISCHARGED ON (B)(6) 2022. AT HOME THE PATIENT WAS LISTLESS AND WAS RE-ADMITTED AS INPATIENT FROM (B)(6) 2022 THRU (B)(6) 2022 WHEN SHE WAS DISCHARGED. AFTER THIS PERIOD, PATIENT DID WELL WITH NO WEIGHT LOSS AND NO DYSPHAGIA. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS CERTAIN. 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 02-DECEMBER-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955878 SENHANCE SENHANCE SURGICAL SYSTEM NAY ASENSUS SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H