BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSESOPHAGEAL ENDOSCOPIC TRANSDUCER

    MDR report key: 1691570 · Received May 14, 2010

    Report

    Report Number
    3019216-2010-00003
    Event Type
    Other
    Date Received
    May 14, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 29, 2010
    Manufacturer
    PHILIPS ULTRASOUND
    Product Code
    ITX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF SERIOUS INJURY WITH THIS EVENT. THE PROBE REMAINS AT THE HOSPITAL AND HAS NOT BEEN EVALUATED BY PHILIPS PERSONNEL. PHILIPS REQUESTED RECEIPT OF THE PROBE FOR EVALUATION. IT WAS CONFIRMED THE CUSTOMER IS USING A NON-APPROVED CHEMICAL (TRISTEL) TO STERILIZE THIS PROBE. PHILIPS USER DOCUMENTATION INSTRUCTS USERS TO USE A PROTECTIVE TRANSDUCER COVER DURING TEE EXAMS.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE RECEIVED AN MHRA ADVERSE INCIDENT REPORT FROM USER FACILITY. (B)(6). THE DETAILS OF THE INCIDENT ARE DESCRIBED AS FOLLOWS: WHILE CLEANING THE PROBE AFTER USE IN A PATIENT AND PRIOR TO BEING STERILIZED, IT WAS NOTICED THAT THE O-RING USED TO SEAL THE AREA BETWEEN THE FLEXIBLE BENDING NECK AND THE SHAFT (INSERTION TUBE) WAS MISSING. IT WAS UNKNOWN WHEN AND WHERE THE O-RING BROKE OFF. NO APPARENT INJURY TO THE PATIENT WAS REPORTED. THE O-RING WAS OBSERVED MISSING AFTER USE IN A VERY SICK POST OP CARDIAC PATIENT AND THE PATIENT CURRENTLY REMAINS IN THE UNIT. THE ANAESTHETIST INVOLVED WITH THE PATIENT PERFORMED A MANUAL INSPECTION OF THE MOUTH AND OROPHARYNX AND PERFORMED A PERCUTANEOUS TRACHEOSTOMY UNDER DIRECT VISION WITH A BRONCHOSCOPE. AFTER INSERTION OF THE TRACHEOSTOMY, THE ANAESTHETIST VISUALIZED THE UPPER AIRWAY WITH THE BRONCHOSCOPE AND PERFORMED SUCTION OF THE AIRWAY SECRETIONS AND THE O-RING WAS NOT OBSERVED. THE PATIENT'S POOR CONDITION PREVENTED ANY FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSESOPHAGEAL ENDOSCOPIC TRANSDUCER X7-2T MTEE ITX PHILIPS ULTRASOUND 453561193191 NB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other