BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCAPOD?

    MDR report key: 25330747 · Received May 29, 2026

    Report

    Report Number
    3005099803-2026-02191
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    January 1, 2026
    Report Date
    May 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ODC
    UDI-DI
    08714729991144
    PMA / PMN Number
    K182275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 01/01/2026 AS NO EVENT DATE WAS REPORTED. BLOCK D2B: SUBSEQUENT PRODUCT CODES FEQ AND OCX. BLOCK H6: IMDRF DEVICE CODE A0509 IS BEING USED TO CAPTURE THE INVESTIGATION RESULTS OF SUCTION BUTTON STICKING. BLOCK H11: ONE SUCTION VALVE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED DAMAGE TO THE CHAMFER OF THE SHAFT IN THE FORM OF A BURR. RETURNED SUCTION VALVE SHAFT FAILED FUNCTIONAL TESTS WITH A SAMPLE SCOPE; THE VALVE WAS ABLE TO BE INSERTED INTO THE SCOPE PORT WITH DIFFICULTY AND WAS STUCK WHEN THE BUTTON WAS PRESSED. PRODUCT ANALYSIS RESULTS INDICATE THAT THE SHAFT DIAMETER OF THE SUCTION VALVE SHAFT WAS WITHIN SPECIFICATION; HOWEVER, DAMAGE TO THE SHAFT CHAMFER WAS NOTED IN THE FORM OF A BURR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS CONFIRMED. PRODUCT ANALYSIS OF THE RETURNED SUCTION VALVE NOTED PHYSICAL DAMAGE IN THE FORM OF A BURR TO THE SHAFT CHAMFER. AN INVESTIGATION TO ADDRESS THIS PROBLEM IS IN PROGRESS. BASED ON ALL GATHERED INFORMATION, THE PROBABLE CAUSE OF THE REPORTED EVENT IS MANUFACTURING DEFICIENCY, INDICATING THAT THE REPORTED DEVICE PROBLEM CAN BE TRACED TO THE MANUFACTURING PROCESS, SPECIFICALLY OF THE SUPPLIER AS THE SHAFT IS A SUPPLIER PROVIDED PART.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT ORCA SUCTION BUTTON WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN PROCEDURE DATE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY PRESSING THE SUCTION BUTTON. WHEN THE STAFF ATTEMPTED TO REMOVE THE BUTTON, THEY ALSO ENCOUNTERED DIFFICULTY DETACHING IT FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SUCTION BUTTON STICKING. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472675 ORCAPOD? PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE ODC BOSTON SCIENTIFIC CORPORATION SUV-633 0037267329 08714729991144

    Patients

    Seq Age Sex Outcome Treatment
    1