BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSDUCER X8-2T

    MDR report key: 8621810 · Received May 17, 2019

    Report

    Report Number
    3019216-2019-00023
    Event Type
    Injury
    Date Received
    May 17, 2019
    Report Date
    April 30, 2019
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    ITX
    UDI-DI
    00884838069718
    PMA / PMN Number
    K163120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH EVALUATION OF THE X8-2T MODEL TRANSDUCER IDENTIFIED EXTENSIVE DAMAGE TO THE DEVICE. INITIAL VISUAL INSPECTION NOTED THE TIP SHELL HAD SCRAPE MARKS AND APPEARED MELTED. PROTEIN BUILD UP, DISCOLORED CABLE AND KNOBS, WORN I-TUBE AND A WRINKLED ARRAY WINDOW WERE ALSO EVIDENT. THE EVALUATION CONCLUDED THE APPEARANCE AND CONDITION OF THE TIP SHELL WOULD NOT HAVE BEEN CAUSED BY THE INSERTION OR USE WITHIN A PATIENT AND WOULD HAVE BEEN PRESENT PRIOR TO USE. THE EXACT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED, HOWEVER, PHILIPS CONCLUDES THAT THIS IS NOT A MANUFACTURING OR DESIGN BASED DEFECT AND IS INDICATIVE OF IMPROPER MAINTENANCE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    INITIAL VISUAL INSPECTION IDENTIFIED A ROUGH SURFACE ON THE DISTAL TIP OF THE TRANSDUCER, ADJACENT TO THE LENS. FURTHER EVALUATION OF THE TRANSDUCER WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS RETURN AND INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ENCOUNTERING AN INCIDENT WHERE A PATIENT SUSTAINED AN INJURY DURING AN EXAMINATION WITH AN X8-2T MODEL TRANSDUCER. UPON COMPLETION OF A TRANSESOPHAGEAL ECHOCARDIOGRAM STUDY, BLOOD WAS FOUND ON THE TRANSDUCER AS IT WAS WITHDRAWN FROM THE PATIENT. FURTHER INVESTIGATION FOUND THE PATIENT HAD RECEIVED A LACERATION TO THEIR ESOPHAGUS. THE INJURY WAS TREATED MEDICALLY AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415369 TRANSDUCER X8-2T TRANSDUCER ITX PHILIPS ULTRASOUND, INC 989605455171 B295RQ 00884838069718

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention