BEUDAMED
    FDA Adverse Event Injury Summary report: N

    #9 DEAN SCISSORS

    MDR report key: 9376258 · Received November 26, 2019

    Report

    Report Number
    1416605-2019-00018
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 26, 2019
    Manufacturer
    HU-FRIEDY MFG. CO. LLC
    Product Code
    EGN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE WAS NOT RETURNED TO HU-FRIEDY. SINCE THE DEVICE WAS NOT RETURNED, AS PART OF THE EVALUATION, RETURNS HISTORY FOR THE DEVICE PART CODE WAS REVIEWED AND WAS NOTED TO HAVE A DOWNWARD TREND SINCE (B)(6) 2018 AND NONE OF THOSE S9 SCISSORS RETURNED WERE MANUFACTURED IN 2019. DUE TO THE LOW RETURN AND COMPLAINT RATE AND SINCE A DETAILED EVALUATION COULD NOT BE PERFORMED BECAUSE OF NO INSTRUMENT RETURNED, NO FURTHER ACTION WAS TAKEN. SHOULD THE DEVICE BE RETURNED, A DETAILED EVALUATION WILL BE DONE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SUTURING AT THE END OF A DENTAL IMPLANT PROCEDURE, THE DEAN SCISSORS BROKE AT THE HINGE AND THE TIP EXTENSION OF ONE SIDE FELL DOWN THE PATIENT'S THROAT. THE USE OF THE DEAN SCISSORS DURING A DENTAL IMPLANT PROCEDURE IS TO CUT 3.0 CHROMIC SUTURE AT THE END OF THE PROCEDURE. A PHARYNGEAL CURTAIN WAS USED THROUGHOUT THE PROCEDURE UNTIL THE ACTUAL SUTURING PORTION. FOLLOWING UNSUCCESSFUL RETRIEVAL ATTEMPT BY DIRECT VISUALIZATION WITH MCGILL FORCEPS, THE PATIENT WAS TRANSFERRED FIRST TO THE LOCAL HOSPITAL, THEN TO A TERTIARY CARE HOSPITAL, WHERE THE INSTRUMENT WAS RETRIEVED ENDOSCOPICALLY UNDER GENERAL ANESTHESIA. THERE WAS NO REPORT OF ANY COMPLICATIONS FOLLOWING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170106 #9 DEAN SCISSORS SCISSORS, SURGICAL TISSUE, DENTAL EGN HU-FRIEDY MFG. CO. LLC S9

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R