BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 20790648 · Received November 27, 2024

    Report

    Report Number
    9610595-2024-23724
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    October 1, 2024
    Report Date
    February 25, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO PROVIDE AN UPDATE TO FIELD D8. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS LIKELY AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A SURGICAL PROCEDURE WHILE USING THE SUBJECT DEVICE. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE AND NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    H6 HEALTH EFFECT - CLINICAL CODE 4581 - APPROPRIATE TERM / CODE NOT AVAILABLE IS USED TO REFLECT MUCOSAL INJURY, CAPNOPERITONEUM, SUBCUTANEOUS EMPHYSEMA, AND REFLUX ESOPHAGITIS. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERORAL ENDOSCOPIC MYOTOMY: SHORT VERSUS LONG ESOPHAGEAL MYOTOMY FOR ACHALASIA CARDIA: A RANDOMIZED CONTROLLED NONINFERIORITY TRIAL". LITERATURE SUMMARY BACKGROUND AND AIMS: THE APPROPRIATE LENGTH OF ESOPHAGEAL MYOTOMY IN PERORAL ENDOSCOPIC MYOTOMY (POEM) FOR ACHALASIA CARDIA REMAINS UNCLEAR. THIS STUDY AIMED TO COMPARE THE OUTCOME OF SHORT (= 3 CM) AND LONG (= 6 CM) ESOPHAGEAL MYOTOMY IN PATIENTS WITH TYPE I AND II ACHALASIA CARDIA. METHODS: THIS SINGLE-BLINDED, RANDOMIZED CONTROLLED NONINFERIORITY TRIAL WAS CONDUCTED AT A TERTIARY CENTER BETWEEN JULY 2021 AND DECEMBER 2021. PATIENTS WITH ACHALASIA TYPES I AND II WERE RANDOMIZED INTO SHORT (=3 CM) AND LONG (=6 CM) ESOPHAGEAL MYOTOMY GROUPS. THE PRIMARY OUTCOME OF THE STUDY WAS CLINICAL SUCCESS (ECKARDT SCORE =3) 1 YEAR AFTER THE PROCEDURE. THE SECONDARY OUTCOMES INCLUDED A COMPARISON OF TECHNICAL SUCCESS, OPERATING DURATION, OCCURRENCE OF INTRAOPERATIVE ADVERSE EVENTS, ALTERATIONS IN INTEGRATED RELAXATION PRESSURE (IRP), CHANGE IN BARIUM COLUMN HEIGHT AFTER 5 MINUTES (1 MO), AND GASTROESOPHAGEAL REFLUX DISEASE (3 MO) BETWEEN THE GROUPS. RESULTS: FIFTY-FOUR PATIENTS WERE RANDOMIZED INTO THE SHORT (N=27) OR LONG (N=27) ESOPHAGEAL MYOTOMY GROUPS. TECHNICAL SUCCESS RATES WERE 100% (27/27) AND 96.3% (26/27) IN SHORT MYOTOMY (SM) AND LONG MYOTOMY (LM) GROUPS, RESPECTIVELY. THE CLINICAL SUCCESS RATES WERE 96.3% (26/27) AND 96.2% (25/26) IN THE SM AND LM GROUPS, RESPECTIVELY (P=0.998). THE MEAN ( ±SD) LENGTH OF THE ESOPHAGEAL MYOTOMY WAS 2.75±0.36 CM IN THE SM AND 6.69±1.35 CM IN THE LM GROUPS (P<0.001). THE MEAN ( ±SD) PROCEDURE TIME FOR THE SM AND LM GROUPS WAS 61.22±8.44 AND 82.42±14.70 MINUTES (P<0.001), RESPECTIVELY. THE MEAN INTEGRATED RELAXATION PRESSURE (IRP), ECKARDT SCORE, ADVERSE EVENTS, REFLUX ESOPHAGITIS, SYMPTOMATIC GASTROESOPHAGEAL REFLUX DISEASE, AND ESOPHAGEAL ACID EXPOSURE (>6%) DID NOT DIFFER SIGNIFICANTLY BETWEEN THE 2 GROUPS FOLLOWING POEM TREATMENT. CONCLUSIONS: SHORT MYOTOMY IS NONINFERIOR TO LONG MYOTOMY IN TERMS OF CLINICAL SUCCESS, GASTROESOPHAGEAL REFLUX DISEASE, AND INTRAOPERATIVE ADVERSE EVENTS AT THE SHORT-TERM FOLLOW-UP (P>0.05). SHORT MYOTOMY RESULTED IN A REDUCED OPERATIVE TIME (P< 0.05). ADVERSE EVENTS THE ADVERSE EVENTS CONSIDERED WERE THOSE THAT LED TO PROLONGATION OF HOSPITAL STAY OR OCCURRED INTRAOPERATIVELY OR POSTOPERATIVELY, SUCH AS CAPNOPERITONEUM REQUIRING NEEDLE ASPIRATION AND MUCOSAL INJURIES REQUIRING CLIP CLOSURE AND BLEEDING. NO MAJOR ADVERSE EVENTS WERE REPORTED IN THIS STUDY. TEN PATIENTS (18.9%) HAD MINOR INTRAOPERATIVE ADVERSE EVENTS, WITH CAPNOPERITONEUM REQUIRING NEEDLE ASPIRATION IN 3 PATIENTS AND MUCOSAL BREACH REQUIRING ENDOCLIPS IN 2 OTHERS. IN BOTH GROUPS, OTHER INSUFFLATION-RELATED ADVERSE EVENTS, SUCH AS CAPNOPERITONEUM, SUBCUTANEOUS EMPHYSEMA, AND MINOR INTRAOPERATIVE BLEEDING EPISODES, WERE NOT STATISTICALLY SIGNIFICANT. REFLUX ESOPHAGITIS WAS FOUND IN 18.5% AND 30.7% OF PATIENTS IN THE SM AND LM GROUPS, RESPECTIVELY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS SHORT MYOTOMY (SM) MINOR BLEEDING - 3 PATIENTS MUCOSAL INJURIES - 1 PATIENT INSUFFLATION-RELATED EVENTS -CAPNOPERITONEUM - 4 PATIENTS -NEEDLE ASPIRATION - 1 PATIENT -SUBCUTANEOUS EMPHYSEMA - 1 PATIENT REFLUX ESOPHAGITIS - 18.5% PATIENTS. LONG MYOTOMY (LM) MINOR BLEEDING - 2 PATIENTS MUCOSAL INJURIES - 1 PATIENT INSUFFLATION-RELATED EVENTS -CAPNOPERITONEUM - 6 PATIENTS -NEEDLE ASPIRATION - 2 PATIENTS -SUBCUTANEOUS EMPHYSEMA - 1 PATIENT REFLUX ESOPHAGITIS - 30.7% PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368815 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H D-201-11804| FD-410LR| KD-645L| UCR