BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 3

    MDR report key: 21478158 · Received February 27, 2025

    Report

    Report Number
    9610614-2025-00013
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    February 10, 2025
    Report Date
    February 27, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K191234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE APC, ESU, AND WATERJET WERE THOROUGHLY INSPECTED/TESTED (NOTE: THE HYBRIDAPC PROBE WAS DISPOSED OF AFTER THE GMA INTERVENTION WORK AND WAS NOT AVAILABLE FOR AN EVALUATION.). A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, A POWER OUTPUT CHECK, ETC. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR EACH OF THE DEVICES. ADDITIONALLY, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) OF THE UNITS AND THE HYBRIDAPC PROBE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE RISK OF A PERFORATION AFTER A GMA PROCEDURE IS A KNOWN COMPLICATION AND DESCRIBED IN THE STUDY PROTOCOL (NOTE: A PERFORATION DURING SUCH AN INTERVENTION IS SERIOUS, BUT RARE.). MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE EVENT (E.G., PATIENT RELATED CONDITIONS, SETTINGS, APPLICATION TIME, ETC.); THEREFORE, A CONCLUSIVE DETERMINATION OF THE SPECIFIC CAUSE OF INCIDENT CANNOT BE DETERMINED. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC)/ELECTROSURGICAL UNIT [ESU/GENERATOR, MODEL VIO 3, PART NUMBER (P/N) 10160-000, SERIAL NUMBER (S/N) (B)(6) SYSTEM WITH A WATERJET MODEL ERBEJET 2, P/N 10150-000, S/N (B)(6) WAS INVOLVED IN A PATIENT INCIDENT UPON A TREATMENT AS PART OF THE GASTRIC MUCOSAL ABLATION (GMA) STUDY, "SAFETY AND FEASIBILITY OF HYBRIDAPC FOR GASTRIC MUCOSAL ABLATION IN THE MANAGEMENT OF PATIENTS WITH CLASS ILL OBESITY (HAPC-GMA BRA)". THE EQUIPMENT WAS USED WITH AN ERBE HYBRIDAPC PROBE (P/N 20150-015, LOT NUMBER WO382353) AND ERBE WATERJET PUMP CARTRIDGE (P/N 20150-300). A SECOND SESSION GMA TREATMENT/PROCEDURE WAS PERFORMED. IN ACCORDANCE WITH THE STUDY PROTOCOL, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR 24-HOUR OBSERVATION. DURING THE NIGHT, THE PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN AND VOMITING. AS A RESULT, THE PATIENT RECEIVED ANALGESIA. WHEN THE CONDITION WORSENED AND THE PAIN PERSISTED, FURTHER DIAGNOSTICS WERE CARRIED OUT. THE PATIENT WAS DIAGNOSED WITH A RETROPERITONEAL GASTRIC PERFORATION (STOMACH, BACK WALL, CLASSIFICATION: CLAVIEN-DINDO IIIB). EXPLORATORY VIDEO LAPAROSCOPY WAS PERFORMED, WITH CLOSURE OF THE GASTRIC PERFORATION IN THE POSTERIOR WALL, INSERTION OF A DRAIN (NOTE: THE DATE OF THE DIAGNOSIS AND SURGERY WAS (B)(6)2025.). ADDITIONAL HOSPITALIZATION FOLLOWED. THE PATIENT'S CONDITION WAS STABLE, AND THE POSTOPERATIVE DEVELOPMENT WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659673 ERBE APC 3 ARGON PLASMA COAGULATION UNIT GEI ERBE ELEKTROMEDIZIN GMBH APC 3

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Hospitalization| R