BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC CO2 REGULATION UNIT

    MDR report key: 22014245 · Received May 13, 2025

    Report

    Report Number
    3002808148-2025-07842
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    January 13, 2025
    Report Date
    May 29, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    HIF
    PMA / PMN Number
    K081173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H6. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, A RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED AND A DEFINITIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THERE WAS NO MALFUNCTION DOCUMENTED ON THE SUBJECT DEVICE AND THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE AUTHOR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: "EFFECTIVENESS AND SAFETY OF FULL-THICKNESS VERSUS CIRCULAR MUSCLE MYOTOMY IN PERORAL ENDOSCOPIC MYOTOMY: A RETROSPECTIVE SINGLE-CENTER ANALYSIS OF 152 PATIENTS. ¿ LITERATURE SUMMARY: ABSTRACT. BACKGROUND: ACHALASIA IS A PRIMARY ESOPHAGEAL MOTILITY DISORDER, WHICH SHOWS IMPAIRED RELAXATION OF THE LOWER ESOPHAGEAL SPHINCTER (LES) AND THE ABSENCE OF PERISTALSIS, LEADING TO DYSPHAGIA, WEIGHT LOSS, AND CHEST PAIN. IN RECENT YEARS, PERORAL ENDOSCOPIC MYOTOMY (POEM) HAS BECOME A POPULAR METHOD FOR TREATING ACHALASIA. HOWEVER, THE EFFECTIVENESS AND SAFETY OF FULL-THICKNESS MYOTOMY (FTM) VERSUS CIRCULAR MUSCLE MYOTOMY (CMM) IN POEM REQUIRE FURTHER INVESTIGATION. METHODS: THIS RETROSPECTIVE SINGLE-CENTER ANALYSIS STUDIED (B)(4) PATIENTS WHO UNDERWENT POEM SURGERY AT THE GENERAL HOSPITAL OF THE WESTERN THEATER COMMAND FROM (B)(6)2014 TO (B)(6) 2023. PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE DEPTH OF MYOTOMY: THE FTM GROUP AND THE CMM GROUP. PARAMETERS SUCH AS SURGICAL SUCCESS RATE, PROCEDURE TIME, AND MYOTOMY LENGTH WERE EVALUATED, AND TREATMENT EFFICACY WAS ASSESSED BASED ON THE ECKARDT SCORE. POSTOPERATIVE COMPLICATIONS AND EFFICACY WERE ALSO MONITORED. RESULTS: TECHNICAL SUCCESS WAS ACHIEVED IN BOTH GROUPS, WITH SHORTER PROCEDURE TIMES IN THE FTM GROUP (P < 0.05). THERE WERE NO SIGNIFICANT DIFFERENCES IN POSTOPERATIVE ECKARDT SCORES AND SYMPTOM IMPROVEMENT BETWEEN THE FTM AND CMM GROUPS. THE INCIDENCE OF ADVERSE EVENTS WAS SIMILAR IN BOTH GROUPS. THE INCIDENCE OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) SEEMED TO BE HIGHER IN THE FTM GROUP, ALTHOUGH THIS DIFFERENCE WAS NOT STATISTICALLY SIGNIFICANT (P = 0.051). TYPE OF ADVERSE EVENTS AND NUMBER OF PATIENTS: LARYNGEAL EDEMA - (B)(4) PATIENTS. SUBCUTANEOUS EMPHYSEMA - (B)(4) PATIENTS. PNEUMOTHORAX - (B)(4) PATIENTS. PNEUMOPERITONEUM - (B)(4) PATIENTS. BLEEDING DURING PROCEDURE - (B)(4) PATIENTS. DELAYED HEMORRHAGE - (B)(4) PATIENTS. INFECTION - (B)(4) PATIENTS. PLEURAL EFFUSION - (B)(4) PATIENTS. IMPAIRED CONSCIOUSNESS - (B)(4) PATIENT. POST-OPERATIVE PAIN - (B)(4) PATIENTS. CONCLUSION: FOR PATIENTS WITH ACHALASIA, THERE WERE NO SIGNIFICANT DIFFERENCES IN SHORT-TO-MEDIUM-TERM TREATMENT EFFICACY AND SAFETY BETWEEN FTM AND CMM IN POEM. ALTHOUGH FTM SIGNIFICANTLY REDUCED PROCEDURE TIME, IT MAY LEAD TO A HIGHER INCIDENCE OF GERD. MORE CASES ARE NEEDED IN THE FUTURE TO EXPLORE THE MORE APPROPRIATE MYOTOMY FOR DIFFERENT ACHALASIA SUBTYPES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967586 ENDOSCOPIC CO2 REGULATION UNIT CO2 REGULATION UNIT HIF SHIRAKAWA OLYMPUS CO., LTD. UCR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown