BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBEFLO CLEVERCAP® HYBRID CO2 TUBING/CAP SETS

    MDR report key: 24941771 · Received April 21, 2026

    Report

    Report Number
    3020712480-2026-00016
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ERBE MEDICAL. LLC
    Product Code
    FEQ
    UDI-DI
    04065655000436
    PMA / PMN Number
    K132340
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    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. IN THIS REPORTED CASE, THE SETS ARE NOT INTENDED TO BE USED WITH BIPOLAR GOLD PROBES (BUT ONLY WITH ERBE ACCESSORIES AND DESIGNATED WATER BOTTLES AND SCOPES). MOST LIKELY, THE CHANGE OF THE SET'S CONNECTOR IS ASSOCIATED WITH THE REPORTED ISSUE; NEVERTHELESS, THE USE OF THE SETS WITH BIPOLAR GOLD PROBES IS OFF LABEL. 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 UNCONTROLLABLY LEAKED. SPECIFICALLY, WHEN THE IRRIGATION TUBING OF A SET IS CONNECTED TO A BIPOLAR GOLD PROBE, IT LEAKS FROM THE PROBE. ANOTHER LOT OF THE SAME PART NUMBER [LOT NUMBER (L/N) WO471077, DATE OF MANUFACTURING (DOM) 10/14/25, AND EXPIRATION DATE (EXP. DATE) 10/13/28 WAS ALSO A PART OF THE COMPLAINT. THE SETS WERE ALSO BEING USED WITH A CO2 OLYMPUS® CONNECTOR TUBES (PART NUMBER 20325-219, UDI: (B)(4), L/N WO458250, DOM 05/13/25, AND EXP. DATE 05/12/28; L/N WO465958, DOM 08/13/25, AND EXP. DATE 08/12/28; AS WELL AS L/N WO465959, DOM 08/13/25, AND EXP. DATE 08/12/28). NO INJURY TO ANY PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593185 ERBEFLO CLEVERCAP® HYBRID CO2 TUBING/CAP SETS CO2 TUBING/CAP SETS FEQ ERBE MEDICAL. LLC WO470770 04065655000436

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown