BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGERY PROBE PLUS II

    MDR report key: 2990028 · Received March 5, 2013

    Report

    Report Number
    3005075853-2013-01039
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K912492
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT HAD THE SHAFT SHEATH AND ELECTRODE WERE DAMAGED AT THE INSTRUMENT TIP. THE TIP OF THE ELECTRODE WAS BENT AND CAUSED THE DAMAGE TO THE SHEATH. THE ELECTRODE WAS INSPECTED AND IT WAS FOUND ATTACHED TO THE INSTRUMENT. CAUTION SHOULD BE TAKEN NOT TO RETRACT THE ELECTRODE INTO THE SHEATH WHEN THE TIP IS BENT. NO CONCLUSION COULD BE REACHED AS TO HOW THE TIP OF THE ELECTRODE WAS BENT

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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 LADG, THE ELECTRODE WAS DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93037 ELECTROSURGERY PROBE PLUS II LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK J4C292

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE