BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUR 8550810 10PK OPHTHALMIC 1MM

    MDR report key: 1986202 · Received February 11, 2011

    Report

    Report Number
    1045254-2011-00010
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    HOG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER, DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION. THE RECORD OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT RECORD. THIS PRODUCT WAS BEING USED FOR TREATMENT, AND NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ABNORMAL CONDITIONS OR IRREGULARITIES THAT SUGGEST FAULTY MANUFACTURING. THE PRODUCT IS INSPECTED FOR THE QUALITY OF WORKMANSHIP (INCLUDES CUTTING EDGE). THE PVC TUBING (USED TO COVER/PROTECT TIP DURING PACKAGE TRANSPORT) IS PLACED ONTO PART AND IS PART OF THE ACCEPTANCE CRITERIA PER THE SPECIFICATION. THE ANALYSIS OF THE RAW MATERIAL (COMPONENT LEVEL) USED ON THE FINISHED GOODS MEETS SPECIFICATION. OVERALL- THE ANALYSIS OF THE RETURNED PRODUCT VS UNUSED PRODUCT REVEALED NO CLEAR DISTINCTION; THUS, WE COULD SEE NO FAULT WITH THE PRODUCT. NO EVIDENCE OF LOOSE FOREIGN MATTER/BODY WAS RETURNED WITH PART. THE "FOREIGN BODY" FOUND IN SURGICAL AREA (PATIENT'S EYE) IS UNKNOWN. PATIENT CURRENT CONDITION: "THE PATIENT IS DOING FINE."

    Description of Event or Problem · 1

    THE MEDWATCH WAS RECEIVED IN THE MAIL FROM THE (B)(4) FROM THE USER/FACILITY. THIS MEDWATCH NOTIFICATION CAME THROUGH (B)(4). (B)(4). THE MEDWATCH STATED THAT THE PATIENT WAS SEEN IN URGENT CARE. THE DOCTOR WAS ATTEMPTING TO REMOVE A RUST RING WITH AN OPHTHALMIC BURR DEVICE. THE BURR DEVICE THAT WAS USED CREATED METAL SHARDS THAT WENT INTO THE PATIENT'S EYE, LEAVING A METALLIC FOREIGN BODY AFTER USE. THE PATIENT WAS REFERRED TO OPHTHALMOLOGY FOR FOLLOW UP. THE PATIENT WAS INFORMED REGARDING THE BURR ISSUE. THE PATIENT DID NOT COMPLAIN OF VISION DISTURBANCE FOLLOWING PROCEDURE. ALCAINE DROPS WERE USED PREVIOUS TO PROCEDURE SO PATIENT REMAINED TOPICALLY ANESTHETIZED UPON DISCHARGE TO THE OPHTHALMOLOGY OFFICE FOLLOWING THE DEVICE MALFUNCTION. IT APPEARS THAT THE PLASTIC SHEATHS INSIDE THE SEALED PACKAGES ARE NOT INTACT. THE CUSTOMER RETURNED ONE BURR USED IN SURGERY. THE CUSTOMER ALSO RETURNED STERILE PACKS OF BURR FROM THE REPORTED LOT 68379800. EXAMINATION OF USED SAMPLE INDICATED NO METAL SHAVINGS ON BURR. NO DEFECTS FOUND WITH BURR- BURR HEAD FULLY INTACT. EXAMINATION OF STERILE BURR INDICATED NO METAL SHAVINGS. NO DEFECTS FOUND WITH BURR AND NO DEFECTS FOUND WITH TIP COVER. THE COMPARISON OF THE RETURNED USED COMPLAINT SAMPLE VS RETURNED UNUSED SAMPLE SHOWS NO CLEAR DISTINCTION DIFFERENCE IN PRODUCT SHAPE. THE WEIGHT COMPARISON OF THE RETURNED USED PART MEASURED 0.6103G VS UNUSED NEW PART MEASURED 0.6090G. THESE RESULTS SUGGEST BURR DID NOT FRAGMENT DURING USE. NO SIGNIFICANT AMOUNT OF THE USED BURR HEAD MATERIAL WAS LOST DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR 8550810 10PK OPHTHALMIC 1MM BURR, CORNEAL, BATTERY-POWERED HOG MEDTRONIC XOMED, INC. 8550810 68379800

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention