BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 14082921 · Received April 12, 2022

    Report

    Report Number
    8010047-2022-06107
    Event Type
    Injury
    Date Received
    April 12, 2022
    Date of Event
    December 21, 2019
    Report Date
    May 25, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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 RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. "THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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 RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE."

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED ¿PRIMARY EXPERIENCE OF SMALL BOWEL POLYPECTOMY WITH BALLOON-ASSISTED ENTEROSCOPY IN YOUNG PEDIATRIC PEUTZ¿JEGHERS SYNDROME (PJS) PATIENTS,¿ A PATIENT EXPERIENCED A MINOR PERFORATION AFTER A PROCEDURE USING AN EVIS LUCERA SMALL INTESTINE VIDEOSCOPE. STUDY AIM: THIS PROSPECTIVE STUDY FOCUSED ON THE EFFECTIVENESS AND SAFETY OF BAE-FACILITATED POLYPECTOMY IN SMALL BOWEL FOR YOUNG PEDIATRIC PJS. METHOD: PJS PATIENTS (AGED 0¿14 YEARS OLD) WITH BAE (INCLUDING BOTH SINGLE-BALLOON AND DOUBLE-BALLOON ENTEROSCOPIES) WERE INCLUDED FROM 1 SEPTEMBER 2012 TO 30 APRIL 2018. THE DEMOGRAPHIC DATA, MEDICAL HISTORY, AND DETAILS OF BAE WERE RECORDED. RESULTS BAE-RELATED COMPLICATIONS AND SYMPTOM RELIEF AFTER BAE WERE EVALUATED AND COMPARED BETWEEN THE PJS PATIENTS AGED 5¿10 YEARS OLD (THE YOUNGER PEDIATRIC GROUP) AND THOSE AGED 11¿14 YEARS OLD (THE OLDER PEDIATRIC GROUP). A TOTAL OF 41 PEDIATRIC PJS PATIENTS (5¿14 YEARS OLD) SUBJECTED TO 82 BAES WERE INCLUDED. BAE FACILITATED POLYPECTOMY WAS PERFORMED FOR 33 CHILDREN (80.5%), AND 242 POLYPS IN SMALL BOWEL WERE REMOVED. FOR 10 (24.4%) PATIENTS, ONE OR MORE GIANT POLYPS (MAXIMUM DIAMETER LARGER THAN 5 CM) WERE REMOVED. FOR EIGHT PATIENTS, NO POLYPECTOMY WAS DONE AS NO POLYPS WERE OBSERVED (SIX SUBJECTS) OR NOT SUITABLE FOR BAE-FACILITATED POLYPECTOMY (TWO SUBJECTS) BECAUSE OF HIGH RISK OF PERFORATION. THE COMPLICATION RATES OF BAE AND BAE-FACILITATED POLYPECTOMY WERE 1.2% (1/82) AND 1.8% (1/55), AND THE SYMPTOM RELIEF RATE WAS 70.8% (17/24). COMPARED WITH THE OLDER PEDIATRIC GROUP, THE YOUNGER PEDIATRIC GROUP SHOWED NO INCREASED BAE COMPLICATION RATE (0.0% VS. 5.0%, P = 0.488) AND A COMPARABLE RATE OF SYMPTOM RELIEF AFTER BAE THERAPY (80.8% VS. 55.6%, P = 0.356). CONCLUSIONS: BAE-FACILITATED POLYPECTOMY IN YOUNG PEDIATRIC PJS IS SAFE AND EFFECTIVE. ONLY ONE PROCEDURE RESULTED IN A MINOR PERFORATION OF THE WOUND WHEN A LARGE POLYP (ABOUT 3.0 CM × 4.0 CM) WAS BEING RESECTED. THIS EVENT OCCURRED IN AN 11- YEAR-OLD BOY WITH PJS FAMILY HISTORY AND PREVIOUS POLYPECTOMY OPERATIONS IN STOMACH AND COLON. HE WAS ASYMPTOMATIC, AND SMALL BOWEL POLYPS HAD BEEN DETECTED IN THE PREVIOUS COLON SURGERY. THE MINOR PERFORATION WAS SUCCESSFULLY CLOSED BY A CLIP. AFTER THE BAE PROCEDURE, NO SIGNS OF PERFORATION OR INFECTION WERE PRESENTED, AND THE BOY WAS DISCHARGED 4 DAYS AFTER BAE. NO BAE-RELATED COMPLICATION WAS EXPERIENCED FOR THOSE NON-POLYPECTOMY PROCEDURES. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323712 EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA OLYMPUS MEDICAL SYSTEMS CORP. SIF-Q260

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention| O