BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON CONTROL UNIT

    MDR report key: 14760302 · Received June 21, 2022

    Report

    Report Number
    8010047-2022-10494
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    June 22, 2021
    Report Date
    July 29, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    UDI-DI
    04953170239533
    PMA / PMN Number
    K071254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. 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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE A CORRECTION AND 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 ¿IMPACT OF SCOPE EXCHANGE FROM A LONG SINGLE BALLOON ENTEROSCOPE TO A GASTROSCOPE DURING ENTEROSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN PATIENTS WITH SURGICALLY ALTERED ANATOMY,¿ PATIENTS EXPERIENCED ADVERSE EFFECTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-CQ260. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SIF-Q260. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ST-SB1. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS OBCU. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS D-201-10704. BACKGROUND/AIMS: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN PATIENTS WITH SURGICALLY ALTERED ANATOMY (SAA) IS CHALLENGING TO GASTROINTESTINAL ENDOSCOPISTS. THE AIM OF THIS STUDY WAS TO EVALUATE THE IMPACT OF SCOPE EXCHANGE FROM A LONG SINGLE BALLOON ENTEROSCOPE (SBE) TO A GASTROSCOPE DURING SBE-ASSISTED ERCP (SBE-ERCP) IN PATIENTS WITH SAA. METHODS: PATIENTS WHO UNDERWENT SBE-ERCP BETWEEN FEBRUARY 2019 AND OCTOBER 2020 WERE RETROSPECTIVELY IDENTIFIED. INTUBATION SUCCESS, SCOPE EXCHANGE SUCCESS, CANNULATION SUCCESS, AND THERAPEUTIC SUCCESS WERE ANALYZED ALONG WITH COMPLICATIONS. RESULTS: FIFTY-SIX PATIENTS WITH VARIOUS SAAS UNDERWENT SBE-ERCP PROCEDURES, INCLUDING BILLROTH II SUBTOTAL GASTRECTOMY (B-II, N=13), PYLORUS-PRESERVING PANCREATO-DUODENECTOMY (PPPD, N=6), ROUX-EN-Y HEPATICOJEJUNOSTOMY (REY HJ, N=4), AND TOTAL GASTRECTOMY WITH REY ANASTOMOSIS (TG REY, N=33). OVERALL INTUBATION, CANNULATION, AND THERAPEUTIC SUCCESS RATES WERE 89.3%, 82.1%, AND 82.1%, RESPECTIVELY. THERAPEUTIC SUCCESS RATES DID NOT DIFFER SIGNIFICANTLY AMONG THE TYPE OF SAA. SUCCESSFUL SCOPE EXCHANGE RATE AFTER SUCCESSFUL INTUBATION WAS SIGNIFICANTLY HIGHER IN NATIVE PAPILLA (B-II AND TG REY, 83.3%, 35/42) COMPARED TO BILIOENTERIC ANASTOMOSIS (PPPD AND REY HJ, 0%, 0/8, P<0.001). INTUBATION SUCCESS, SCOPE EXCHANGE, AND CANNULATION SUCCESS WERE ASSOCIATED WITH THERAPEUTIC SUCCESS (P<0.001). IN MULTIVARIATE ANALYSIS, SUCCESSFUL SCOPE EXCHANGE WAS THE ONLY FACTOR RELATED TO CANNULATION SUCCESS (P=0.02). THE MAJOR COMPLICATION RATE WAS 1.8% (ONE PERFORATION). CONCLUSIONS: SBE-ERCP IS A SAFE AND EFFECTIVE PROCEDURE TO TREAT BILIARY PROBLEMS IN PATIENTS WITH SAA. SUCCESSFUL SCOPE EXCHANGE MAY LEAD TO HIGHER THERAPEUTIC SUCCESS BY WAY OF CANNULATION SUCCESS. ADVERSE EVENTS OCCURRED IN SIX OF 56 PATIENTS (10.7%). ONE CASE OF PERFORATION OCCURRED IN TG REY THAT REQUIRED SURGICAL REPAIR OF INTESTINAL PERFORATION AND BILIARY STONE REMOVAL. ASYMPTOMATIC HYPERAMYLASEMIA OCCURRED IN FIVE CASES (TWO IN B-II, THREE IN TG REY). THERE WERE NO OTHER COMPLICATIONS INCLUDING BLEEDING, POST-ERCP PANCREATITIS, OR PROCEDURE-RELATED DEATHS. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622828 BALLOON CONTROL UNIT BALLOON CONTROL UNIT FDA OLYMPUS MEDICAL SYSTEMS CORP. OBCU 04953170239533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other