BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9T-RS

    MDR report key: 16903760 · Received May 10, 2023

    Report

    Report Number
    9610482-2023-00002
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 3, 2023
    Report Date
    June 28, 2023
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    ITX
    PMA / PMN Number
    K181727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A: PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. BLOCK D4, UDI: (B)(4)(PROBE),(CONSOLE). BLOCK E1: THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. LEGAL MANUFACTURER: HCS HORTEN - STRANDPROMENADEN 45 NORWAY HORTEN VESTFOLD, N-3191, HCS WUXI - NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE CHINA WUXI JIANGSU, 214028. INITIAL INFORMATION PROVIDED INDICATES THE PROBE HAD REACHED THE TEMPERATURE LIMIT AND THE SYSTEM STOPPED TRANSMITTING ENERGY AS DESIGNED, AND LOGFILE ANALYSIS CONFIRMS THIS. ADDITIONALLY, THE GEHC SERVICE ENGINEER PERFORMED PRELIMINARY PROBE ANALYSIS AND NO PROBE MALFUNCTION WAS OBSERVED. GE HEALTHCARE'S INVESTIGATION AS TO WHETHER THE ADVERSE EVENT IS A THERMAL BURN OR A CHEMICAL BURN, AND WHETHER OR NOT THERE IS A MALFUNCTION IS ON-GOING AT THIS TIME.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE S INVESTIGATION HAS COMPLETED, AND IT IS CONCLUDED THAT THE PATIENT BURN WHILE USING A VIVID IQ WITH A 9T-RS PROBE DURING CARDIAC SURGERY HAS NOT OCCURRED DUE TO DEVICE MALFUNCTION. GEHC S INVESTIGATION OF THE CAUSE OF THE PATIENT BURN CONSIDERED MULTIPLE HAZARDOUS SITUATIONS: OVERHEATING, PROBE DAMAGE ALLOWING DISINFECTANT TO GET INSIDE, AND PROBE REPROCESSING. OVERHEATING AND PROBE DAMAGE WERE RULED OUT THROUGH DEVICE EVALUATION. ADDITIONALLY, IT WAS OBSERVED FROM THE VISUAL INSPECTION OF THE PROBE THAT THERE WAS SIGNIFICANT BUILD-UP OF BIOMATTER RESIDUE WHICH MAY SOAK UP DISINFECTANT FLUIDS WHEN THE PROBE IS NOT WIPED AS INDICATED WITHIN THE PROBE REPROCESSING INSTRUCTIONS. BASED UPON FURTHER ASSESSMENTS, IT WAS CONCLUDED THAT THE AMOUNT OF RESIDUE OBSERVED ON THE PROBE WOULD NOT HAVE OCCURRED IF THE GE HEALTHCARE PROBE REPROCESSING INSTRUCTIONS REGARDING WIPING OF THE ENDOSCOPE DURING PRE-CLEANING AND AFTER EACH RINSING STEP WERE FOLLOWED. LASTLY, THE COMPLAINT FILE WAS REVIEWED FOR SIMILAR ISSUES AND THERE IS NO INDICATION OF ANY SYSTEMIC ISSUE NOR AN ISSUE WITH PROBE REPROCESSING INSTRUCTIONS. RISK MITIGATIONS CURRENTLY IN PLACE ARE VERIFIED TO BE EFFECTIVE AND HAVE REDUCED THE RISK AS FAR AS POSSIBLE (AFAP) WITHIN THE CLINICAL USE SCENARIO. BASED UPON THIS INVESTIGATION IT IS CONCLUDED THAT NO CORRECTIVE OR PREVENTIVE ACTION IS NECESSARY. THE CUSTOMER WILL BE PROVIDED GEHC¿¿S INVESTIGATION CONCLUSIONS, AND THEY WILL BE PROVIDED WITH AN OPPORTUNITY TO DISCUSS GEHC¿¿S PROBE REPROCESSING TECHNIQUES IN FURTHER DETAIL.

    Description of Event or Problem · 0

    GEHC RECEIVED A FOREIGN USER FACILITY INJURY REPORT OF A PEDIATRIC PATIENT INJURY POST HEART VALVE REPLACEMENT SURGERY. THE PATIENT WAS UNDERGOING HEART VALVE SURGERY WHERE THE 9T-RS WAS BEING USED ALONG WITH THE VIVID IQ FOR VISUALIZATION TO ASSIST IN THE SURGERY. AFTERWARDS, IT WAS NOTED THAT THE PATIENT MAY HAVE HAD A BURNED ESOPHAGUS. SYMPTOMS INCLUDE BLACK SALIVA, A BROWN HEMI CIRCLE IN THE ANTERIOR ESOPHAGUS AND A BROWN SPOT ON THE LIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687009 9T-RS 9T-RS ULTRASOUND TRANSDUCER ITX GE VINGMED ULTRASOUND AS 31452/6030037WX0

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Required Intervention| H