BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS (LCS**) - PISTOL GRIP 36

    MDR report key: 1974845 · Received January 31, 2011

    Report

    Report Number
    3005075853-2011-00362
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE CLAMP ARM DETACHED FROM THE INNER TUBE. THE DETACHED CLAMP ARM WAS NOT RETURNED ALONG WITH THE DISPOSABLE INSTRUMENT SO NO CONCLUSION CAN BE DRAWN AS TO THE TISSUE PAD CONDITION. POSSIBLE CAUSES FOR THE CLAMP ARM DETACHMENT INCLUDE: NOT CLOSING THE TRIGGER WHEN INTRODUCING OR REMOVING THE DEVICE THROUGH THE TROCAR, OR ENTANGLEMENT IN FIBROUS TISSUE. ADDITIONALLY, THE DEVICE WAS RECEIVED WITH THE BLADE SCRATCHED AND CRACKED, HOWEVER, THIS CONDITION IS NOT RELATED TO THE REPORTED TISSUE PAD ISSUE. THE DEVICE WAS CONNECTED TO A TEST HAND PIECE AND A GENERATOR AND WAS FUNCTIONALLY TESTED. DURING TESTING, AN ERROR CODE 5 WAS DISPLAYED AND THE BLADE FURTHER BROKE OFF. CONTACT WITH METAL (STAPLES, CLIPS) OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS BEING ACTIVATED, DURING PRE-OP OR GENERAL USE, MAY RESULT IN CRACKED OR BROKEN BLADES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, THE TISSUE PAD WAS REMOVED AND FALL INTO THE PATIENT. NO FURTHER INFORMATION WERE PROVIDED. THEY REMOVED THE TISSUE PAD FROM PATIENT. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS (LCS**) - PISTOL GRIP 36 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK F4PK8W

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE