BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIP

    MDR report key: 22013568 · Received May 13, 2025

    Report

    Report Number
    9614641-2025-00724
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    January 13, 2025
    Report Date
    May 30, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    PKL
    PMA / PMN Number
    K963160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LEGAL MANUFACTURER'S INVESTIGATION. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. ¿

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

    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 152 PATIENTS WHO UNDERWENT POEM SURGERY AT THE GENERAL HOSPITAL OF THE WESTERN THEATER COMMAND FROM MAY 2014 TO MAY 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 - 2 PATIENTS. SUBCUTANEOUS EMPHYSEMA - 16 PATIENTS. PNEUMOTHORAX - 4 PATIENTS. PNEUMOPERITONEUM - 17 PATIENTS. BLEEDING DURING PROCEDURE - 7 PATIENTS. DELAYED HEMORRHAGE - 14 PATIENTS. INFECTION - 7 PATIENTS. PLEURAL EFFUSION - 48 PATIENTS. IMPAIRED CONSCIOUSNESS - 1 PATIENT. POST-OPERATIVE PAIN - 22 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368254 CLIP CLIP PKL AOMORI OLYMPUS CO., LTD. HX-600-135 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown