BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWIVEL DIRECT FLOW ULTRASONIC SCALING INSERT

    MDR report key: 1240845 · Received November 18, 2008

    Report

    Report Number
    1416605-2008-00003
    Event Type
    Other
    Date Received
    November 18, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 13, 2008
    Manufacturer
    HU-FRIEDY MFG, INC.
    Product Code
    ELC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION INDICATES THAT THE FAILURE MODE FOR THIS INSTRUMENT WAS NORMAL CYCLIC FATIGUE. NO PRODUCT MALFUNCTION WAS DETECTED. THIS INSTRUMENT WAS MANUFACTURED IN JUNE OF 2007 AND WITH TYPICAL USAGE, THE EXPECTED LIFE OF AN ULTRASONIC INSERT IS APPROXIMATELY 1 YEAR.

    Description of Event or Problem · 1

    ON (B) (6) 2008, A YOUNG MALE PT WAS HAVING A ROUTINE CLEANING AND SHORTLY AFTER THE HYGIENIST STARTED THE PROCEDURE, SHE NOTICE THAT THE TIP OF A HU-FRIEDY ULTRASONIC INSERT HAD BROKEN OFF. THE PT WAS SENT TO A NEARBY EAR, NOSE & THROAT (ENT) SPECIALIST FOR FOLLOW-UP IMMEDIATELY. THE DOCTOR PERFORMED AN ENDOSCOPY ON THE PT TO ATTEMPT RETRIEVAL OF THE TIP BUT WAS NOT ABLE TO FIND IT. THE PT WAS SENT HOME AND TOLD THAT THE TIP SHOULD PASS ON ITS OWN. AFTER A 2ND FOLLOW-UP VISIT WITH THE ENT, IT WAS DETERMINED THAT NO FURTHER MEDICAL TREATMENT WAS NECESSARY. HU-FRIEDY MANUFACTURING WAS MADE AWARE OF THIS INCIDENT ON (B) (6) 2008. THE BROKE ULTRASONIC INSERT WAS SENT TO HU-FRIEDY FOR EVALUATION AND ARRIVED ON 11/05/2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIVEL DIRECT FLOW ULTRASONIC SCALING INSERT ULTRASONIC SCALER ELC HU-FRIEDY MFG, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention