BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1823462 · Received September 2, 2010

    Report

    Report Number
    3005075853-2010-05032
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER AN EXHAUSTIVE SEARCH OF FILE RECORDS, PHYSICAL DEVICE INVENTORY, AND RECEIVING RECORDS, THE DEVICE FOR THE REPORTED EVENT COULD NOT BE LOCATED. BECAUSE THE DEVICE IS NOT AVAILABLE, NO ANALYSIS COULD BE PERFORMED. FILE WILL BE REOPENED IF THE DEVICE IS LOCATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE BLADE WAS BROKEN OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR COMMENTED THAT THE BLADE HAD NOT TOUCHED SOMETHING HARD.

    Description of Event or Problem · 1

    THE PT RECEIVED HIS SCS SYSTEM INCLUDING PERCUTANEOUS LEADS ON (B)(6)2005. IT WAS REPORTED THAT THE PT WAS EXPERIENCING OVERSTIMULATION. AN X-RAY REVEALED THAT ONE OF THE LEADS HAD MIGRATED. THE PHYSICIAN SURGICALLY REPOSITIONED THE LEAD. FOLLOW UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE LEAD WAS NOT RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE