BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE'S CO2 TUBING/CAP SETS

    MDR report key: 24799984 · Received April 7, 2026

    Report

    Report Number
    3020712480-2026-00006
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ERBE MEDICAL. LLC
    Product Code
    FEQ
    UDI-DI
    04065655001099
    PMA / PMN Number
    K162152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SETS WERE RETURNED ON 03/25/26 TO ERBE USA AND FORWARDED TO ERBE MEDICAL LLC ON 04/01/26. NEVERTHELESS, WE HAVE 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 LEAKING 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 ANY PROMINENT CAUSES ARE DETERMINED AND/OR REMEDIES ARE IMPLEMENTED TO RESOLVE THE LEAKING, A FOLLOW-UP MDR WILL BE FILED. IN ADDITION, IF ANY OTHER CONCLUSIONS ARE ASCERTAINED UPON THE EVALUATION OF THE RETURNED SETS INVOLVED WITH THE LEAKING, THEN A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HYBRID CO2 TUBING/CAP SETS FOR FUJINON SCOPES LEAKED FROM THE IRRIGATION LINE. ALSO, CAPS ARE SKIPPING THREADS AND POPPING OFF WHEN THREADED ON TO BAXTER BOTTLES IF NOT DONE PERFECTLY. ANOTHER SIMILAR PRODUCT {HYBRID CO2 TUBING/CAP SETS FOR FUJIFILM SCOPES, PART NUMBER 20325-248, LOT NUMBERS W4467056 [DATE OF MANUFACTURING (DOM) 08/28/25, EXPIRATION DATE 08/27/2028] AND WO471252 (DOM 10/16/25, EXPIRATION DATE 10/15/2028), UDI: (B)(4)} WAS A PART OF THE COMPLAINT. THE SETS WERE USED WITH AN ERBE IRRIGATION PUMP MODEL EIP2 AND ERBE CO2 INSUFFLATOR MODEL ECO2. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864725 ERBE'S CO2 TUBING/CAP SETS CO2 TUBING/CAP SETS FEQ ERBE MEDICAL. LLC WO468760 04065655001099

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown