BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIBLE OLYMPUS ENDOSCOPE

    MDR report key: 7701982 · Received July 19, 2018

    Report

    Report Number
    8010047-2018-01400
    Event Type
    Injury
    Date Received
    July 19, 2018
    Report Date
    July 19, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES HAVE NOT BEEN RETURNED TO OMSC. OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE MODEL NUMBERS AND SERIAL NUMBERS WERE NOT PROVIDED FROM THE FACILITY. THERE WAS NO MALFUNCTION REPORT OF THE SUBJECT DEVICE CONCERNING THE EVENTS. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ON JUNE 20, 2018, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿NONAMPULLARY DUODENAL ADENOMAS RARELY RECUR AFTER COMPLETE ENDOSCOPIC RESECTION: A SWISS EXPERIENCE INCLUDING A LITERATURE (PIERO V. VALLI ET AL. DIGESTION 2017; 96: 149¿157). THE LITERATURE REVIEWED ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURES FOR 78 PATIENTS FROM 2006 TO 2016 IN ORDER TO EXAMINE THE OUTCOME OF EMR OF DUODENAL POLYPS WITH REGARDS TO SHORT-TERM (DUODENAL PERFORATION, BLEEDING) AND LONG-TERM (BLEEDING) ADVERSE EVENTS AS WELL AS THE FREQUENCY OF ADENOMA RECURRENCE. IN THE PROCEDURES, FLEXIBLE STANDARD OLYMPUS ENDOSCOPES WERE REPORTEDLY USED. IN 49 (62.8%) OF THE CASES, PROPHYLACTIC HEMOSTASIS USING HEMOCLIPS (N = 26, 53.1%), APC ( N = 8, 16.3%), OTSC ® ( N = 6, 12.2%), LOOP LIGATION ( N = 1, 2%) USING OLYMPUS ENDO LOOP OR A COMBINATION OF THESE ( N = 8, 16.3%) WAS PERFORMED AT THE TIME OF PRIMARY ENDOSCOPIC RESECTION. THERE WAS NO INFORMATION ON THE NUMBER AND MODEL NAMES OF OLYMPUS ENDOSCOPES USED IN THE PROCEDURES. IN THE LITERATURE, FOLLOWING 19 CASES OF COMPLICATIONS IN 19 PATIENTS WERE REPORTED; INTRAPROCEDURAL BLEEDING (10 CASES) ALL OF THE 10 (12.8%, 7 MINOR, 3 MAJOR) INTRAPROCEDURAL BLEEDINGS WERE STOPPED BY ENDOSCOPIC MEASURES. POSTPROCEDURAL BLEEDING (7 CASES) IN 7 CASES (9%), DELAYED BLEEDING (MAJOR 6, MINOR 1) WAS NOTICED AFTER THE PRIMARY INTERVENTION. ENDOSCOPIC HEMOSTASIS WAS THEN ACHIEVED IN ALL CASES. THE MEAN TIME FROM THE ENDOSCOPIC ADENOMA RESECTION TO OCCURRENCE OF DELAYED BLEEDING WAS 52 H (RANGE 5¿240 H). OF THE PATIENTS WITH DELAYED BLEEDING, ONE PATIENT UNDERWENT RESECTION WHILE STILL ON A LOW-DOSE TREATMENT WITH ACETYL SALICYLIC ACID. A SECOND PATIENT HAD STOPPED THE ANTIPLATELET MEDICATION MORE THAN 7 DAYS BEFORE THE POLYPECTOMY. THE REMAINING 5 PATIENTS DID NOT TAKE ANY ANTICOAGULANTS. IN 4 OUT OF THESE 7 PATIENTS WITH DELAYED BLEEDING, PROPHYLACTIC ENDOSCOPIC HEMOSTASIS OR HEMOSTASIS OF A PROCEDURAL BLEEDING HAD ALREADY BEEN PERFORMED (APC AND OR CLIP APPLICATION). PERFORATION (2 CASES) TWO OUT OF 78 (2.6%) PATIENTS HAD A DUODENAL PERFORATION THAT WAS SUCCESSFULLY CLOSED USING AN OVER -THE -SCOPE CLIP (OTSC ®). SINCE THERE WAS NO INFORMATION ON THE MODEL OF THE DUNODENOVIDEOSCOPE THAT WAS USED IN EACH CASES, OMSC IS SUBMITTING NINETEEN MDRS ACCORDING TO THE NUMBER OF PATIENTS HAVING COMPLICATIONS. THIS IS FOURTEEN OF NINETEEN REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543910 FLEXIBLE OLYMPUS ENDOSCOPE UNKNOWN FDF OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other