BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE MEDICAL

    MDR report key: 5797727 · Received July 15, 2016

    Report

    Report Number
    3007593903-2016-00003
    Event Type
    Injury
    Date Received
    July 15, 2016
    Date of Event
    April 1, 2016
    Report Date
    May 5, 2016
    Manufacturer
    BOVIE MEDICAL
    Product Code
    HOG
    PMA / PMN Number
    K950520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT WAS NOT CONFIRMED. CUSTOMER WAS REMOVING FOREIGN/METALLIC PART FROM PATIENT EYE, THE CUSTOMER USED A BOVIE OPHTHALMIC BURR (1/2MM) LOT # 0914B MANUFACTURING DATE 2014-09-02 EXPIRATION DATE 2018-09 AND CLAIMED THAT IMMEDIATELY THE BURR WAS ACTIVATED ON THE EYE METAL SHARDS STARTED TO COME OFF OF THE TIP. THE DEVICE AND TWO ADDITIONAL BURRS SEALED FROM SAME MANUFACTURING AND STERILE LOT WERE RECEIVED FOR EVALUATION ON 4/19/2016. THE FOLLOWING PROCESS WAS FOLLOWED TO EVALUATE THE RETURNED DEVICES: DEVICE WAS DECONTAMINATED. DEVICES WERE VISUALLY INSPECTED USING MAGNIFICATION AND NO EVIDENCE OF A BROKEN PART WAS OBSERVED. A COMPARISON BETWEEN THE SUBJECTED DEVICE AND A SAMPLE SUPPLIED BY THE CUSTOMER FOR THE SAME MANUFACTURING LOT NUMBER AND STERILE LOT NUMBER WAS PERFORMED. BOTH SAMPLES WERE SET SIDE BY SIDE AND 30 X MAGNIFICATIONS WAS USED TO OBSERVE ANY DIFFERENCE BETWEEN THEM AND NO EVIDENCE OF DEGRADATION OR DAMAGES WERE OBSERVED BOTH PIECES LOOKS IDENTICAL. A TOP VIEW WAS ALSO OBSERVED AND BOTH PIECE SHOWS THE STAR SHAPE, BOTH PIECES LOOK IDENTICAL THEY ARE NOT SHOWING ANY SIGN OF BROKEN PIECES. BOTH PIECES LOOKS INTACT AND PER SPECIFICATION. AS PER SPECIFICATION THE DIMENSIONS FOR THE TIP SHALL BE 0.026-0.022 IN USING CALIPER THE TIP WAS MEASURED AND FOUND TO BE 0.024 IN. TIP WAS FOUND TO BE WITHIN SPECIFICATION. IT WAS CONFIRMED DURING THE INITIAL CONVERSATION WITH OFFICE MANAGER THAT THE DOCTOR WAS REMOVING FOREIGN METALLIC PARTS FROM THE PATIENT EYE. IT WAS ALSO CONFIRMED THAT THE DR. WAS USING A NON BOVIE BRAND HANDLE. AS PER INVESTIGATION THIS COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    DOCTOR WAS REMOVING FOREIGN/METALLIC PARTS FROM PATIENT EYE AND REPLACEABLE BURRS WAS USED. DOCTOR ALLEGED THAT THE SHARDS OF THE AB05 TIP BROKE OFF IMMEDIATELY WHEN ACTIVATED IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452190 BOVIE MEDICAL BURR 1/2MM 10/BOX HOG BOVIE MEDICAL 0914B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention