BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6VT-D PROBE

    MDR report key: 6949422 · Received October 13, 2017

    Report

    Report Number
    9610482-2017-00006
    Event Type
    Injury
    Date Received
    October 13, 2017
    Report Date
    December 22, 2017
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    ITX
    PMA / PMN Number
    K131514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE'S INVESTIGATION HAS FINISHED AND CONCLUDED: THE TRISTEL TRIO WIPES HIGH-LEVEL DISINFECTION REPROCESSING METHOD, WHICH THE CUSTOMER WAS USING, IS UNSUITED FOR USE IN THE OPERATING ROOM SCENARIO ON TRANSESOPHAGEAL PROBES WITH VISIBLE ENDOSCOPE WEAR AND THIS LIMITATION IS NOT COVERED IN THE CLEANING & DISINFECTION INFORMATION ISSUED BY GE WITH THE INITIAL SALE OF THIS PROBE. IT IS NOTED THAT INFORMATION WAS ACCORDING TO THE REQUIREMENTS OF APPLICABLE STANDARDS AND THEREFORE CORRECT AT THE TIME, BUT THROUGH THE KNOWLEDGE ACQUIRED THROUGH THIS INVESTIGATION IT IS NOW CONSIDERED INCOMPLETE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    BECAUSE OF AN INCREASE OF INCIDENCE OF ENTEROBACTER AEROGENETIC BACTERIAL INFECTIONS AFTER HEART SURGERY, THE CUSTOMER PERFORMED AN INVESTIGATION TO DETERMINE ROOT CAUSE. THE CUSTOMER REPORTED TO GE THE POSSIBLE CAUSE OF THE BACTERIAL INFECTIONS MAY RESULT FROM INTRAOPERATIVE USE OF TEE PROBES. THEIR INVESTIGATION CONCLUDED THEY WERE FOLLOWING GE¿S MANUFACTURER SPECIFICATIONS FOR CLEANING AND DISINFECTION, AND FURTHER INVESTIGATION OF ONE OF THE PROBES ALSO DETERMINED BACTERIA WAS PRESENT IN A CRACK FORMED WHERE ADHESIVE IS APPLIED AT THE POINT WHERE THE BENDING TIP IS JOINED TO THE ENDOSCOPE. HOSPITAL FOUND ACTIVE MICRO-ORGANISMS ON THE PROBE AFTER THEY REPROCESSED IT. HOWEVER, THEY DID NOT FIND ENTEROBACTER BACTERIA. THE PROBE WAS ANALYZED BY GE AND THERE WERE NO PUNCTURES FOUND VIA VISUAL AND ELECTRICAL EVALUATION. THE DEFLECTION COVER AND SCAN-HEAD OF THE ENDOSCOPE WERE NOT COMPROMISED. LOOSE POTTING WAS OBSERVED BETWEEN THE DEFLECTION COVER AND SCAN-HEAD OF THE ENDOSCOPE WHICH MAY EXPLAIN THE PRESENCE OF MICRO-ORGANISMS AFTER REPROCESSING. THE CUSTOMER EXPLAINED IN WRITING THAT THEY WILL NOT PROVIDE PATIENT INFORMATION INCLUDING QUANTITY OF PATIENTS AFFECTED NOR OUTCOMES. BOTH THE CUSTOMER AND GE'S INVESTIGATIONS ARE ONGOING, AND A FOLLOW-UP REPORT WILL BE SUPPLIED UPON CONCLUSION OF THE INVESTIGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728905 6VT-D PROBE TRANSESOPHAGEAL ULTRASOUND PROBE ITX GE VINGMED ULTRASOUND AS KN100110 203598

    Patients

    Seq Age Sex Outcome Treatment
    1 Other