BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBEFLO CLEVERCAP® HYBRID CO2 TUBING/CAP SETS

    MDR report key: 24916643 · Received April 17, 2026

    Report

    Report Number
    3020712480-2026-00012
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ERBE MEDICAL. LLC
    Product Code
    FEQ
    UDI-DI
    04065655000405
    PMA / PMN Number
    K162152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SETS HAVE NOT BEEN RETURNED FOR ANALYSIS. HOWEVER, WE RECEIVED SIMILAR REPORTS OF SETS LEAKING AT THE DISTAL END OF THE IRRIGATION LINE AND DOWN SCOPES. AT THIS TIME, TWO (2) PRIMARY CAUSES OF THE ISSUE HAVE BEEN DETERMINED: 1. OFF-LABEL USE IN THAT ERBE MEDICAL LLC SETS ARE BEING USED WITH OTHER MANUFACTURERS PORT CONNECTORS (NOTE: PER THE NOTES ON USE FOR THE SET'S, ONLY ERBE ACCESSORIES (I.E., ERBE PORT CONNECTORS), ETC. ARE TO BE USED WITH ERBE TUBING/CAP SETS. 2. A CHANGE HAD BEEN MADE TO THE SET'S CONNECTOR. CURRENTLY SETS ARE NOW BEING PRODUCED WITH THE PREVIOUS CONNECTOR TO MINIMIZE/ELIMINATE LEAKING. OTHER CONTRIBUTING CAUSES OF LEAKING AT THE END OF SCOPES ARE ALSO BEING INVESTIGATED. IF DEVICES ARE RETURNED AND THE EVALUATION FINDINGS ARE DIFFERENT THAN WHAT HAS ALREADY BEEN REPORTED AND/OR ANY OTHER PROMINENT CAUSES ARE DETERMINED AND/OR REMEDIES ARE IMPLEMENTED TO RESOLVE LEAKING, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR OLYMPUS® SCOPES & UCR LEAKED FROM THE DISTAL END OF THE SCOPES WHEN USED WITH A BOSTON SCIENTIFIC CONNECTORS. ADDITIONALLY, THE CAPS ARE SKIPPING THREADS AND POPPING OFF WHEN THREADED ON TO A BAXTER BOTTLE IF NOT DONE PERFECTLY. IN ONE CASE, DURING AN UPPER ENDOSCOPY, A PATIENT ASPIRATED DUE TO EXCESS WATER LEAKING FROM THE DISTAL END OF THE OLYMPUS SCOPE. NO INJURIES OCCURRED. OTHER LOT NUMBERS OF THE SAME PART NUMBER [LOT NUMBER (L/N) WO469446, DATE OF MANUFACTURING (DOM) 09/25/25, AND EXPIRATION DATE (EXP. DATE) 09/24/28; L/N WO471246, DOM 10/15/25, AND EXP. DATE 10/14/28; L/N WO473983, DOM 11/12/25, AND EXP. DATE 11/11/28; AS WELL AS L/N WO473984, DOM 11/12/25, AND EXP. DATE 11/11/28] WERE ALSO A PART OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613495 ERBEFLO CLEVERCAP® HYBRID CO2 TUBING/CAP SETS CO2 TUBING/CAP SETS FEQ ERBE MEDICAL. LLC WO469445 04065655000405

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown