BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6VT-D PROBE

    MDR report key: 2901219 · Received January 4, 2013

    Report

    Report Number
    9610482-2013-00001
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 6, 2012
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    IYN
    PMA / PMN Number
    K120201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT A LATER TIME ON (B)(6)2012, THE USER FACILITY PERFORMED AN ESOPHAGEAL SCOPE, WHICH REVEALED A "10CM RIFT IN THE ESOPHAGUS AND PERFORATION COULD NOT BE EXCLUDED." THIS WAS FIXED IMMEDIATELY BY GI-SURGEONS USING A STENT IN THE ESOPHAGUS. THE USER FACILITY PERFORMED FURTHER ANALYSIS OF THE EVENT AND STATED THAT IT WAS NOT POSSIBLE TO DETERMINE IF THE INJURY WAS DUE TO THE BENT PROBE OR WHETHER THE PROBE TIP WAS BENT DURING INSERTION OR BEFORE EXTRACTION. ADDITIONALLY, THE USER FACILITY ASKED HOW TO DETERMINE WHEN THE PROBE TIP IS IN THE NEUTRAL POSITION. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THE EXACT DATE OF THE EVENT WAS NOT PROVIDED BY THE USER FACILITY. THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 1

    A USER FACILITY IN (B)(6) REPORTED THAT A DVT-D PROBE USED WITH A VIVID E9 ULTRASONIC IMAGING SYSTEM FOR A CRYO-MAZE TREATMENT MAY HAVE CAUSED AN ESOPHAGEAL INJURY THAT REQUIRED SURGICAL INTERVENTION TO PRECLUDE PERMANENT LOSS OF FUNCTION AND/OR A LIFE-THREATENING SITUATION. THE USER FACILITY REPORTED THAT THEY PERFORMED A PRE-OPERATIVE CHECK FOR THE CRYO-MAZE TREATMENT USING THE 6VT-D PROBE, EXTRACTED THE PROBE FROM THE ESOPHAGUS, THEN RE-INSERTED THE PROBE AND THE PROBE STOPPED IMAGING. THE PROBE WAS THEN EXTRACTED. WHEN EXTRACTED, THEY NOTED THE PROBE TIP WAS BENT 180 DEGREES, COVERED WITH BLOOD, AND THE PATIENT WAS BLEEDING FROM THE THROAT. THE PATIENT HAD ACUTE RESPIRATORY AND CIRCULATORY ISSUES. HOWEVER, THE USER FACILITY STATED THEY ARE NOT SURE IF THESE ISSUES WERE RELATED TO THE PROBE OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5054 6VT-D PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER IYN GE VINGMED ULTRASOUND AS KN100100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other