BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURG DEV, BLADES 5MM, OPEN

    MDR report key: 2982225 · Received August 7, 2006

    Report

    Report Number
    1527736-2006-03757
    Event Type
    Malfunction
    Date Received
    August 7, 2006
    Date of Event
    May 29, 2006
    Report Date
    June 2, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    PMA / PMN Number
    K012176
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: (B)(4) 2006. DEVICE A AND F BATCH= A9AW6J, LOT = UNKNOWN, EXPIRATION DATE = 11/01/2010, MFR DATE = 12/01/2005. DEVICE B, C, D, E AND G BATCH = C9C45R, LOT = UNK, EXPIRATION DATE= 02/01/2011, MFR DATE = 03/01/2006. DEVICE H BATCH = A9AX59, LOT = UNKNOWN, EXPIRATION DATE= 11/01/2010, MFR DATE= 12/01/2005. RESULTS: BLADE DAMAGE/ CRACKED TIP. ANALYSIS SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS RESULTS FOUND THAT THE DEVICES (A THRU H) WERE RETURNED WITH THE BLADES SCRATCHED AND CRACKED. THE DEVICES WERE TESTED WITH A GENERATOR AND AN ERROR CODE 5 WAS RECEIVED. THE IDENTIFIED BLADE DAMAGE MAY HAVE OCCURRED FROM EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE. THEREFORE, THE INSTRUCTIONAL INSERT STATES: "AVOID ACCIDENTAL CONTACT WITH ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. CONTACT WITH STAPLES, CLIPS OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY GENERATOR SOLID TONE OR INSTRUMENT ERROR." THE BATCH RECORDS WERE REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE 8 DEVICES DID NOT WORK. THERE WAS NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION SURG DEV, BLADES 5MM, OPEN LFL ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HAND PIECE| GENERATOR