BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE'S CO2 TUBING/CAP SETS

    MDR report key: 24769489 · Received April 2, 2026

    Report

    Report Number
    3020712480-2026-00003
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 2, 2026
    Manufacturer
    ERBE MEDICAL. LLC
    Product Code
    FEQ
    UDI-DI
    04065655000375
    PMA / PMN Number
    K162152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SETS WERE NOT AVAILABLE FOR AN EVALUATION. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH A HYBRID CO2 TUBING/CAP SET FOR OLYMPUS® SCOPES & CO2 IN AN ESOPHAGOGASTRODUODENOSCOPY (EDG). PER THE COMPLAINANT, WATER SHOT DOWN THE AIRWAY OF A PATIENT DURING SCOPE INTUBATION INTO THE ORAL PHARYNX. THE PATIENT ASPIRATED WATER BUT WAS DISCHARGED. HOWEVER, THE PATIENT LATER WENT TO THE EMERGENCY ROOM (ER), WAS HOSPITALIZED, AND RECEIVED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831885 ERBE'S CO2 TUBING/CAP SETS CO2 TUBING/CAP SETS FEQ ERBE MEDICAL. LLC WO469451 04065655000375

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Other| H