BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNIFE

    MDR report key: 1722974 · Received June 11, 2010

    Report

    Report Number
    2523835-2010-00045
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 14, 2010
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED, THIS IS THE FIRST EVENT REPORTED REGARDING THIS ISSUE FOR THIS FACILITY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE LOTS WERE RELEASED BASED ON ALCON'S ACCEPTANCE CRITERIA. ROOT CAUSE: COMPLAINT CONFIRMED. THE KNIFE WAS BEVEL DOWN INSTEAD OF BEVEL UP. THE CAUSE OF THE FAILURE WAS THAT THE BLADE WAS PLACED INTO THE ASSEMBLY AND BEND MACHINE (ABM) RACKING FIXTURE BACKWARDS. IT WAS THEN BENT IN THE WRONG DIRECTION ON THE ABM. THIS NONCONFORMANCE SHOULD HAVE BEEN DETECTED BY THE FINISHING MONITORS. CORRECTIVE ACTION: THIS SAMPLE HAS BEEN SHOWN TO ALL OF THE FINISHING MONITORS THAT WORKED ON THIS WORK ORDER TO MAKE THEM AWARE OF THIS NON-CONFORMANCE. QUALITY ASSURANCE WILL MONITOR RELATED COMPLAINTS AND WILL TAKE ACTION FOR FURTHER OCCURRENCES AS NECESSARY. (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "SUTURE NEEDED TO CLOSE WOUND" (NO CODE AVAILABLE). PRODUCT PROBLEM(S): "CUTTING SURFACE ON WRONG SIDE." (NO CODE AVAILABLE [KNIFE]). THE CUSTOMER REPORTED THAT THE CUTTING SURFACE WAS ON THE WRONG EDGE OF THE KNIFE. THE SURGEON CONTINUED THE PROCEDURE USING THE KNIFE. THE PT REQUIRED A SUTURE TO CLOSE THE WOUND. THE SURGEON IS UNSURE IF THIS WAS RELATED TO THE KNIFE. ADD'L F/U INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992745 786028M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CUSTOM PAK SURGICAL PAK