BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSHIELD

    MDR report key: 19773469 · Received July 18, 2024

    Report

    Report Number
    1528319-2024-00061
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 18, 2024
    Manufacturer
    US ENDOSCOPY
    Product Code
    OCX
    UDI-DI
    00724995183554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING FOLLOW-UP WITH THE DISTRIBUTOR, IT WAS REPORTED THAT THE DEVICE WAS LEAKING AT THE ENDOSCOPE CONNECTION POINT DURING THE PROCEDURE RESULTING IN A SMALL PUDDLE ON THE FLOOR. ADDITIONALLY, IT WAS REPORTED THAT THE USER FACILITY COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THE DEVICE SUBJECT OF THE EVENT WAS RETURNED TO US ENDOSCOPY FOR EVALUATION AND FOUND THAT THE ONE WAY VALVE WAS WORKING PROPERLY. THE REPORTED BACKFLOW COULD NOT BE DUPLICATED. THE REPORTED LEAKING MAY HAVE OCCURRED IF THE LID OF THE BIOSHIELD WAS LEFT OPEN BY USER FACILITY PERSONNEL DURING USE. THE INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING INFORMATION: "IF THE LID OF THE VALVE IS OPENED WHILE ATTACHED TO THE ENDOSCOPE DURING A PROCEDURE, SCOPE SUCTION WILL BE COMPROMISED AND LEAKAGE MAY OCCUR. IF LEAKAGE OCCURS, A STERILE GAUZE SHOULD BE USED TO COVER THE VALVE." THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. THE DISTRIBUTOR OFFERED IN-SERVICE TRAINING TO USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE BIOSHIELD IRRIGATOR; HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THERE WAS BILE BACKFLOW WHILE USING THEIR BIOSHIELD IRRIGATOR. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552511 BIOSHIELD IRRIGATOR OCX US ENDOSCOPY 00711133 (21)6165042 00724995183554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown