BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3022682 · Received March 27, 2013

    Report

    Report Number
    3005075853-2013-01410
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TIP BROKE OFF AFTER USING THE INSTRUMENT FOR DISSECTION, THE SURGEON COMMENTED THAT A LOT OF TISSUE SEEMS TO GET STUCK IN THE JAWS WHEN USING, AFTER ASKING DID HE CLEAN BETWEEN ACTIVATIONS HE SAID YES THAT HE WOULD USUALLY INSTRUCT THE SCRUB TO ACTIVATE IN WATER WITH THE JAWS OPEN BUT COULD NOT RECALL IF HE DID IT DURING THIS CASE. THE TIP CAME OFF THE INSTRUMENT OUTSIDE THE PATIENT BETWEEN ACTIVATIONS. THE TIP HAS BEEN SENT BACK WITH REST OF PRODUCT COMPLAINT. THE SURGEON OPENED A NEW DEVICE TO CONTINUE THE PROCEDURE. WAS THERE ANY CONTACT WITH METAL OR PLASTIC DURING ACTIVATION OF THE DEVICE? NO. WAS THERE ANY TRANSECTION ACROSS STAPLE LINES? NO. HE HAD ONLY USED ACE36E FOR DISSECTION AT THIS POINT HE HAD NOT DONE ANY LAP STAPLING DID ANY PIECE FALL INTO THE PATIENT? NO. THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND RETURNED WITH THE DEVICE. THE REMAINING BLADE PORTION WAS SCRATCHED ¿ EVIDENCE OF CONTACT WITH METAL IN OR OUT OF THE OPERATIVE FIELD. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON THE GEN11 GENERATOR, THE ¿INSTRUMENT ERROR¿ ALERT WAS DISPLAYED; AND WHEN TESTED ON THE GEN04 GENERATOR, AN ERROR CODE 5 (INSTRUMENT ERROR) WAS DISPLAYED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN ERROR CODE 5 OR INSTRUMENT ERROR SCREEN IS BLADE DAMAGE. THE ANALYSIS CONCLUDED THAT THE BLADE BROKE OFF DUE TO CONTACT WITH THE INNER TUBE. THIS DAMAGE WAS MOST LIKELY DUE TO EXCESSIVE SIDE FORCES APPLIED TO THE BLADE WHILE ACTIVATING RESULTING IN BLADE CONTACT WITH THE INNER TUBE.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR PROCEDURE, THE TIP CAME OFF AFTER USING THE INSTRUMENT FOR DISSECTION, THE SURGEON COMMENTED THAT A LOT OF TISSUE SEEMS TO GET STUCK IN THE JAWS WHEN USING. THE TIP CAME OFF THE INSTRUMENT OUTSIDE THE PATIENT BETWEEN ACTIVATIONS. THE TIP HAS BEEN SENT BACK WITH REST OF PRODUCT COMPLAINT. THE SURGEON OPENED AN NEW DEVICE TO CONTINUE THE PROCEDURE. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127003 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE