BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER-VISITEC INTERNATIONAL INC

    MDR report key: 19210151 · Received April 29, 2024

    Report

    Report Number
    1211998-2024-00009
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 9, 2024
    Report Date
    April 29, 2024
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL INC
    Product Code
    HMX
    UDI-DI
    00886158101987
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BVI QUALITY ASSURANCE HAS FOLLOWED ITS INTERNAL PROCEDURE TO CONDUCT THE APPROPRIATE COMPLAINT INVESTIGATION. THE INVESTIGATION INCLUDES A REVIEW OF THE PROCEDURE / TRAINING RECORD AND DEVICE HISTORY RECORDS, AND NO ANOMALIES WERE FOUND. ALL REQUIRED ELEMENTS OF THE DHR WERE APPROPRIATELY FILLED; ALL MANUFACTURING OPERATIONS WERE RECORDED; ALL SIGNATURES AND DATES WERE PRESENT, AND THE LOT PASSED REQUIRED INSPECTIONS. THE RISK ASSESSMENT HAS BEEN PERFORMED AND DUE TO THE FACT THAT THIS COMPLAINT APPEARS TO BE SINGLE AND ISOLATED FOR THE SPECIFIC MODEL WE CONSIDER THE OCCURRENCE AS REMOTE AND THE SEVERITY RISK LEVEL IS STILL ADEQUATE.

    Description of Event or Problem · 0

    IN REFERENCE TO (B)(4), CUSTOMER ALLEGED THAT A SURGEON WAS USING A THE CORTICAL CLEAVING HYDRODISSECTOR (BOLGER) 50X22MM, 25G X7/8 (33DEGREE) BY BVI VISITEC LOT 3465442 EXP 29/02/2028 REF 585159 DURING SURGERY. THE DEVICE WAS IN TACT WHEN OPENED AND WAS USED ONCE AND UPON THE SECOND INSERTION TO THE EYE THE DEVICE WAS NOT CONNECTED LEAVING THE METAL PART IN-SITU OF THE EYE. THE SURGEON RETRIEVED THIS WITH SOME FORCEPS WITH NO FURTHER COMPLICATIONS. A NEW DEVICE OF A DIFFERENT BATCH WAS THEN USED WITH NO PROBLEMS.

    Description of Event or Problem · 0

    IN REFERENCE TO MHRA REPORT (B)(6) CUSTOMER ALLEGED THAT A SURGEON WAS USING A THE CORTICAL CLEAVING HYDRODISSECTOR (BOLGER) 50X22MM, 25G X7/8 (33DEGREE) BY BVI VISITEC LOT 3465442, EXP 29/02/2028, REF 585159 DURING SURGERY. THE DEVICE WAS IN TACT WHEN OPENED AND WAS USED ONCE AND UPON THE SECOND INSERTION TO THE EYE THE DEVICE WAS NOT CONNECTED LEAVING THE METAL PART IN-SITU OF THE EYE. THE SURGEON RETRIEVED THIS WITH SOME FORCEPS WITH NO FURTHER COMPLICATIONS. A NEW DEVICE OF A DIFFERENT BATCH WAS THEN USED WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146521 BEAVER-VISITEC INTERNATIONAL INC 585159 HYDRODISSECTOR .50MM HMX BEAVER-VISITEC INTERNATIONAL INC 585159 3465442 00886158101987

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention