BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 23646209 · Received November 25, 2025

    Report

    Report Number
    9610595-2025-34576
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    September 19, 2025
    Report Date
    November 25, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST PROBABLE CAUSE WAS NOT ESTABLISHED; THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ACHALASIA AND MENTAL RETARDATION IN A CHILD WITH UNIPARENTAL DISOMY OF GDP-MANNOSE PYROPHOSPHORYLASE A (GMPPA) TREATED WITH PER-ORAL ENDOSCOPIC MYOTOMY (POEM)." LITERATURE SUMMARY: ACHALASIA IS A RARE ESOPHAGEAL DISORDER WITH AN INCIDENCE OF 0.11 PER 100,000 ANNUALLY IN CHILDREN. THE MOST COMMON SYNDROME INVOLVING ACHALASIA IS TRIPLE-A SYNDROME (OMIM#231550)¿AN AUTOSOMAL RECESSIVE DISORDER CHARACTERIZED BY ADRENAL INSUFFICIENCY, ACHALASIA, ALACRIMA, AND NEURODEGENERATION. ACHALASIA IS IDENTIFIED IN ALACRIMA, ACHALASIA, AND MENTAL RETARDATION (AAMR) SYNDROME (OMIM#615510)¿AN AUTOSOMAL RECESSIVE DISEASE CAUSED BY LOSS-OF-FUNCTION VARIANTS IN GMPPA. THERE HAVE BEEN 22 PATIENTS REPORTED. AAMR AND TRIPLE-A SYNDROME OVERLAP IN ACHALASIA AND ALACRIMA. ABSENCE OF ADRENAL INSUFFICIENCY IN AAMR AIDS DIFFERENTIATION. AAMR EXHIBITS THE INVOLVEMENT OF MULTIPLE SYSTEMS, SUCH AS MUSCULAR HYPOTONIA AND GAIT ABNORMALITIES. ACHALASIA IS TREATED WITH BALLOON DILATATION, BOTULINUM TOXIN INJECTION, AND HELLER MYOTOMY, AND TREATMENT HAS BEEN REVOLUTIONIZED WITH POEM). POEM HAS BECOME THE MAINSTREAM TREATMENT, WITH FAVORABLE OUTCOMES COMPARED WITH HELLER MYOTOMY AND PNEUMATIC DILATION [1]. INHERITANCE OF A HOMOLOGOUS PAIR OF CHROMOSOMES FROM ONE PARENT (SEGMENTAL OR TOTAL) RESULTS IN UNIPARENTAL DISOMY (UPD), WHICH IS ASSOCIATED WITH THE IMPRINTING AND UNMASKING OF AUTOSOMAL RECESSIVE DISORDERS. HEREIN, WE REPORT AN AAMR CASE WITH MATERNAL UPD OF CHROMOSOME 2 CAUSING THE HOMOZYGOUS MUTATION OF GMPPA. THERE HAVE BEEN NO PREVIOUS REPORTS OF AAMR RESULTING FROM UPD. THIS IS THE YOUNGEST PATIENT WITH AAMR RECEIVING POEM. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS EVENT1: SUBCUTANEOUS EMPHYSEMA (THE PATIENT IS A 2-YEAR-OLD FEMALE) AN INITIAL MUCOSAL INCISION WAS PERFORMED ON THE POSTERIOR ESOPHAGUS 5CM ABOVE THE ESOPHAGOGASTRIC JUNCTION (INCISOR-CARDIA DISTANCE: 23CM). MYOTOMY WAS PERFORMED 4CM ABOVE THE ESOPHAGEAL-GASTRIC JUNCTION AND EXTENDED 1CM INTO THE CARDIA. DURING POEM, THERE WAS BLOATING IN THE RIGHT ABDOMEN. AS NEEDLE DECOMPRESSION DID NOT SHOW RUSHES OF AIR, SUBCUTANEOUS EMPHYSEMA WAS DIAGNOSED. CLOSURE OF MUCOSAL ENTRY WAS APPLIED WITH EIGHT TITANIUM CLIPS. THE TOTAL OPERATING TIME WAS 15 MINUTES. POST-OPERATIVE X-RAY EXCLUDED PNEUMOTHORAX, PNEUMOPERITONEUM, AND PNEUMOMEDIASTINUM. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION IDENTIFIED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673198 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Female ELECTROSURGICAL HEMOSTATIC FORCEPS (FD-410LR)| TITANIUM CLIPS (HX-610¿90)