BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL ATTACHMENT

    MDR report key: 14845091 · Received June 28, 2022

    Report

    Report Number
    8010047-2022-10955
    Event Type
    Injury
    Date Received
    June 28, 2022
    Report Date
    June 28, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE LEGAL MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED. THE LITERATURE ARTICLE CAN BE FOUND AT: HTTPS://DOI.ORG/10.11280/GEE.63.2508. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. 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.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED "STUDY OF 109 CASES BY ENDOSCOPIC TREATMENT (ANTI-REFLUX MUCOSECTOMY: ARMS) FOR ACID SECRETION INHIBITOR (PPI) RESISTANT REFRACTORY GASTROESOPHAGEAL REFLUX DISEASE GERD) (WITH VIDEO) ", THREE PATIENTS EXPERIENCED ADVERSE EFFECTS DURING OR AFTER AN ENDO-REFLUX MUCOSECTOMY (ARMS) USING A DISPOSABLE ELECTROSURGICAL SNARE. STUDY AIM: INVESTIGATE THE EFFICACY OF ARMS IN PATIENTS WITH PPI REFRACTORY GERD. METHOD: RETROSPECTIVE REVIEW OF 109 PATIENTS WITH PPI REFRACTORY GERD WHO UNDERWENT ARMS AND COMPARED THE QUESTIONNAIRE SCORES, ACID-EXPOSURE TIMES, NUMBER OF DEMEESTER SCORE, PROXIMAL REFLUX, AND PPI DISCONTINUATION RATES BEFORE AND AFTER ARMS. RESULTS: SUBJECTIVE SYMPTOMS WERE SIGNIFICANTLY IMPROVED (P<0.01) AND PPI COULD BE DISCONTINUED IN 40-50% OF THE PATIENTS AFTER ARMS. IN ADDITION, IMPROVEMENT IN SUBJECTIVE SYMPTOMS WAS MAINTAINED IN THE 3-YEAR FOLLOW-UP PATIENTS. ACID-EXPOSURE TIME OR DEMEESTER SCORE IMPROVED AFTER ARMS (P<0.01), BUT PROXIMAL REFLUX DID NOT IMPROVE SIGNIFICANTLY (P=0.0846). CONCLUSION: ARMS IS A VALUABLE MINIMALLY INVASIVE TREATMENT FOR PEOPLE WITH PPI REFRACTORY GERD. THE EFFECTIVENESS OF TREATMENT IS DUE TO INHIBITION OF ACID REFLUX BY SCAR FORMATION IN THE CARDIA. TWO POSTOPERATIVE BLEEDING EVENTS OCCURRED IN PATIENTS. THESE PATIENTS WERE TREATED WITH ENDOSCOPIC HEMOSTASIS WITHOUT THE USE OF BLOOD TRANSFUSIONS. MINOR PERFORATION WAS OBSERVED IN ONE PATIENT. THIS PATIENT WAS TREATED WITH ENDOSCOPIC CLIP CLOSURE OF THE DEFECT. NO ADDITIONAL CONSEQUENCES TO THE PATIENTS WERE REPORTED. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY. [TYPE OF ADVERSE EVENTS / NUMBER OF PATIENTS] POSTOPERATIVE BLEEDING 2 CASES. SMALL PERFORATION 1 CASE. THIS ARTICLE INCLUDES 3 REPORTS: (B)(6)/SD-221L-25. (B)(6)/GIF-Q260J. (B)(6)/MAJ-296 THIS REPORT IS 3 OF 3 FOR (B)(6)/MAJ-296.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938321 DISTAL ATTACHMENT DISTAL ATTACHMENT FDS OLYMPUS MEDICAL SYSTEMS CORP. MAJ-296 UNKNOWN(LITERATURE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNK LOT, SERIAL: SD-221L-25,GIF-Q260J