BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 14641731 · Received June 9, 2022

    Report

    Report Number
    8010047-2022-09706
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    March 19, 2021
    Report Date
    July 14, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170334115
    PMA / PMN Number
    K112680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN REPORTED BY THE IMPORTER ON MDR# 2951238 ¿ 2022- 00423. MODEL NUMBER: THE LITERATURE REPORTS GIF-H160, GIF-H170 CHOSEN AS A REPRESENTATIVE PRODUCT. THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND A CORRECTION. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: D4, D8, H6, H10. 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 ARTICLE TITLED ¿USEFULNESS OF FLUOROSCOPY FOR ENDOSCOPIC BALLOON DILATION OF CROHN'S DISEASE-RELATED STRICTURES¿; A PATIENT EXPERIENCED A PERFORATION DURING A PROCEDURE USING ONE OF FOUR OLYMPUS SCOPES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q160. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H180. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-H160. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q160. BACKGROUND: FLUOROSCOPY IS OFTEN USED FOR ENDOSCOPIC BALLOON DILATION (EBD) OF CROHN'S DISEASE (CD)-RELATED STRICTURES. HOWEVER, ITS BENEFIT REMAINS UNCLEAR. AIMS: TO COMPARE EBD WITH (EBDF) AND WITHOUT (EBDNF) FLUOROSCOPIC GUIDANCE IN CD PATIENTS WITH STRICTURES. METHODS: SINGLE-CENTER, NESTED, CASE-CONTROL RETROSPECTIVE STUDY OF EBD FOR CD-RELATED STRICTURES. TECHNICAL AND CLINICAL SUCCESS AND SAFETY OUTCOMES WERE COMPARED BETWEEN EBDF AND EBDNF. RESULTS: A TOTAL OF 122 STRICTURES IN 114 CD PATIENTS WHO UNDERWENT EBD FROM 2010 TO 2018 AT A SINGLE INSTITUTION WERE REVIEWED (44 PATIENTS EBDF VS. 70 EBDNF). ESOPHAGOGASTRODUODENOSCOPY WAS THE APPROACH IN 8 STRICTURES, COLONOSCOPY IN 86, AND DEEP ENTEROSCOPY IN 28. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE RATES OF TECHNICAL AND CLINICAL SUCCESS, NEED FOR REPEAT DILATION AND SURGERY BETWEEN THE TWO GROUPS, ALTHOUGH THE MEAN MAXIMAL ENDOSCOPIC BALLOON DIAMETER WAS LARGER IN THE EBDNF GROUP (17.1 ± 1.9 VS. 14.1 ± 2.5; P < 0.001). THERE WAS ONE PERFORATION IN EBDF AND NO SERIOUS COMPLICATIONS IN EBDNF. IN MULTIVARIATE ANALYSIS, BALLOON SIZE < 15 MM (ODDS RATIO [OR] 6.388; 95% CI 1.96-20.79; P = 0.002) AND MULTIPLE STRICTURES (OR 3.897; 95% CI 1.09-14.01; P = 0.037) WERE ASSOCIATED WITH REPEAT EBD, AND AGE < 50 YEARS (OR 7.178; 95% CI 1.38-37.44; P = 0.019) AND SMALL BOWEL (VS. COLON) LOCATION (OR 7.525; 95% CI 1.51-37.47; P = 0.014) WERE ASSOCIATED WITH THE NEED FOR SURGERY AFTER EBD. CONCLUSIONS: EBD FOR CD-RELATED STRICTURES CAN BE PERFORMED SAFELY AND EFFECTIVELY WITHOUT FLUOROSCOPIC GUIDANCE. BALLOON SIZE, PATIENT AGE, STRICTURE LOCATION, AND MULTIPLICITY ARE ASSOCIATED WITH CLINICAL SUCCESS AND AVOIDANCE OF SURGERY. THERE WAS ONLY ONE SERIOUS ADVERSE EVENT, A PERFORATION WHICH OCCURRED IN ONE PATIENT WHO UNDERWENT DILATION UNDER FLUOROSCOPY. THERE WERE NO PATIENT¿S WHO DEVELOPED SEVERE BLEEDING OR REQUIRED HOSPITALIZATION FOR PAIN AFTER BALLOON DILATION IN EITHER GROUP. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION REPORTED IN ANY PROCEDURE DESCRIBED IN THIS LITERATURE.

    Description of Event or Problem · 0

    CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H180AL.CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-H170.CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H170L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893618 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H170 04953170334115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other