BEUDAMED
    FDA Adverse Event Summary report: N

    PPL SEALER

    MDR report key: 2753277 · Received September 20, 2012

    Report

    Report Number
    1722028-2012-00742
    Date Received
    September 20, 2012
    Date of Event
    August 20, 2012
    Report Date
    August 24, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    KSD
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE STAFF MEMBER DOCUMENTED THAT THERE WAS WHAT APPEARED TO BE PLASMA RESIDUE ON THE SEALER HANDLE. THIS WAS CLEANED BEFORE THE TUBE SEALER WAS SENT FOR INVESTIGATION. THE SEALER IS NOW WITH OUR CONTRACTOR EMG. INITIAL REPORTS FROM EMG INDICATE THAT THEY FOUND RESIDUE OF A SPILL IN THE HANDLE, HOWEVER THIS WAS NOT THE HAND THAT RECEIVED THE RF BURN. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: THE SEALER WAS INSPECTED BY (B)(6). ON INSPECTION, THE SEALER WAS OPERATING WITHOUT FAULT AND NO EVIDENCE COULD BE FOUND THAT COULD CONTRIBUTE TO AN RF BURN. THE SYSTEM WAS TESTED FOR ELECTRICAL INTEGRITY AND DEEMED TO BE SAFE AND OPERATING AS INTENDED BY THE MANUFACTURER. A SMALL AMOUNT OF DRY FLUID RESIDUE WAS FOUND AROUND THE HEAD OF THE SEALER HOWEVER IT WAS DETERMINED THAT IT IS UNLIKELY THAT THIS WOULD HAVE CAUSED AN RF BURN. THE SEALER HEAD HAS BEEN REPLACED AS A PRECAUTION AND WAS SENT BACK TO TERUMO (B)(4) FOR FURTHER ANALYSIS. TERUMO (B)(4) ALSO CONFIRMED THAT THE SEALER IS OPERATING CORRECTLY. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. POSSIBLE ROOT CAUSES INCLUDE THE OPERATOR'S HANDS BEING TOO CLOSE TO THE SEALER HEAD WHILE PERFORMING A SEAL, OPERATING THE SEALER WITHOUT THE SPLASHGUARD, FLUID PRESENT IN THE ELECTRODE AREA DURING USE, WET OR MOIST TUBING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A STAFF MEMBER AT THE CUSTOMER SITE FELT A BURNING SENSATION TO THE TIP OF THE MIDDLE FINGER ON THE LEFT HAND. THE RF BURN WAS TO THE HAND HOLDING THE TUBING BEING SEALED. THE STAFF MEMBER WAS NOT WEARING GLOVES AND THEIR HAND WAS APPROXIMATELY 6 INCHES AWAY FROM THE SEALING ELECTRODES. A PLASTIC SPLASH GUARD WAS IN PLACE. THE SEAL WAS PERFORMED POST DONATION AND POST REMOVAL OF NEEDLE FROM THE DONOR. THE STAFF MEMBER'S HANDS WERE REPORTEDLY DRY PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THE HEAT SEALER HAS BEEN SENT TO OUR CONTRACTOR, EMG, FOR INVESTIGATION. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED. THE EXTENT OF THE INJURY IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE THE PATIENT'S AGE AND WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PPL SEALER PPL SEALER KSD TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1