BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL 3055601 SKEETER OTO-TOOL

    MDR report key: 2193571 · Received August 5, 2011

    Report

    Report Number
    1045254-2011-00057
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC XOMED INC
    Product Code
    ERL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER CLARIFICATION WITH OSB, IT WAS DETERMINED THIS REPORT WAS FILED IN ERROR AS AN MDR REPORTABLE EVENT. PER OSB, THE FACT THAT THE SURGERY WAS CANCELLED DOES NOT MEET THE REGULATORY DEFINITION OF A MDR REPORTABLE EVENT.

    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. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, DURING AN EXPLORATORY TYMPANOTOMY AND LEFT STAPEDECTOMY PROCEDURE THE SURGEON WAS HANDED THE DRILL TO BEGIN THE STAPEDECTOMY , BUT, "THE DRILL WAS CRIMPED SHUT AND WAS UNABLE TO PASS THE BIT." THE SURGEON CANCELLED THE PROCEDURE AT THAT TIME AND INDICATED THE PROCEDURE WOULD HAVE TO BE RESCHEDULED. THE POWERED DRILL IS A SLENDER, LIGHTWEIGHT DRILL HANDPIECE USED WITH BURS, SPECIFICALLY FOR USE IN MIDDLE EAR SURGICAL PROCEDURES, INCLUDING STAPES FOOTPLATE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL 3055601 SKEETER OTO-TOOL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC 3055601 NOT PROVID

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention