BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 3

    MDR report key: 18317534 · Received December 13, 2023

    Report

    Report Number
    9610614-2023-00061
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    December 8, 2023
    Report Date
    December 13, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K191234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) OF THE UNITS. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE INCIDENT. PER PROVIDED DOCUMENTATION "PI DOES NOT BELIEVE THIS TO BE DUE TO A DEVICE DEFICIENCY OR MALFUNCTION.". NEVERTHELESS, A THOROUGH EVALUATION OF THE INVOLVED APC/ESU SYSTEM WITH THE WATERJET UNIT IS BEING PLANNED. IF THERE ARE ANY ISSUES WITH THE EQUIPMENT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED AS PART OF THE DOCUMENTATION FOR THE STUDY. "PATIENT UNDERWENT HER 2ND GMA SESSION ON (B)(6) 2023. HER ABLATION WAS UNEVENTFUL. AT THE CONCLUSION OF THE PROCEDURE, SHE WAS NOTED TO HAVE SIGNIFICANT ABDOMINAL DISTENTION AND HAD NOT PASSED FLATUS DURING THE PROCEDURE. SHE WAS TRANSPORTED TO PACU AND WITH CHANGE OF POSITION AND NURSING ASSISTANCE, SHE WAS ABLE TO PASS SIGNIFICANT FLATUS WITH RESOLUTION OF HER ABDOMINAL DISTENTION. SHE WAS DISCHARGED FROM THE FACILITY WITH ABSENCE OF PAIN, DISTENTION, OR OTHER SYMPTOMS. AT 19:00 SHE TEXTED ME TO REPORT THAT SHE HAD NEW SWELLING OF HER NECK AND FACE. SHE DENIED SOB, DIFFICULTY SWALLOWING, OR ABDOMINAL PAIN. WITHIN THE NEXT FEW MINUTES, HER LEFT EYE WAS SWOLLEN SHUT. I ADVISED HER TO REPORT TO OUR LOCAL HOSPITAL FOR EVALUATION. SHE PRESENTED TO THE HOSPITAL AT 19:55. SHE UNDERWENT A NON-CONTRAST CT NECK, CHEST, ABDOMINAL, AND PELVIS. THESE STUDIES WERE SIGNIFICANT FOR PNEUMOPERITONEUM AND SMALL BILATERAL PNEUMOTHORAXES. HER LABS WERE SIGNIFICANT FOR LEUKOCYTOSIS (WBC 17.0), ELEVATED LIVER TRANSAMINASES (ALP 111, ALT 58), BUT WERE OTHERWISE UNREMARKABLE. SHE DENIED ABDOMINAL PAIN, HAD NORMAL OXYGEN SATURATION, AND WAS IN NO DISTRESS. VITAL SIGNS ON PRESENTATION: TEMP 98.1, HR 89, BP 153/94, RESP 19, O2 SAT 94%. THE PATIENT WAS SEEN BY GENERAL/BARIATRIC SURGERY. WE THEN DISCUSSED HER CASE. HER CT FINDINGS WERE OUT OF PROPORTION TO HER EXAM AND SURGERY WAS NOT CONVINCED THAT SHE HAD A PERFORATION. WE ELECTED TO PERFORM A REPEAT CT WITH ORAL CONTRAST. THIS STUDY WAS NEGATIVE FOR GASTRIC LEAK, THOUGH SHOWED POSSIBLE EXTENSION OF CONTRAST WITHIN, BUT NOT THROUGH, THE GASTRIC WALL. AFTER DISCUSSION WITH MYSELF AND THE PATIENT, WE ELECTED TO PROCEED WITH A DIAGNOSTIC LAPAROSCOPY TO 1) DECOMPRESS THE PNEUMOPERITONEUM, PRESUMED TO BE ARGON AND 2) ASSESS TO THE STOMACH TO CONFIRM THE PRESENCE OR ABSENCE OF PERFORATION. OR CASE STARTED: 0355 PROCEDURE FINISHED: 0431 IN PACU: 0445 THE PATIENT REPORTED IMMEDIATE RELIEF OF DISCOMFORT AND GAS PRESSURE. THE NEXT MORNING, SHE WAS TOLERATING CLEAR LIQUIDS WITHOUT DIFFICULTY, AMBULATING, AND CLEARED FOR DISCHARGE HOME. THE FINAL DIAGNOSIS WAS POST-PROCEDURAL PNEUMOPERITONEUM, WITHOUT GASTRIC PERFORATION, SECONDARY TO ARGON GAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581219 ERBE APC 3 AGON PLASMA COAGULATION UNIT GEI ERBE ELEKTROMEDIZIN GMBH APC 3

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Hospitalization