BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 1030270 · Received April 17, 2008

    Report

    Report Number
    1226420-2008-00001
    Event Type
    Injury
    Date Received
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    TISSUELINK MEDICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL DID NOT REPORT THE LOT# ASSOCIATED WITH THE DEVICE. TISSUELINK MEDICAL INC. HAS MADE 2 ATTEMPTS TO GET THE PRODUCT BACK FROM THE HOSPITAL IN ORDER TO COMPLETE AN EVALUATION OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD FOR ALL LOTS SHIPPED TO THIS HOSPITAL SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. IF TISSUELINK MEDICAL INC. RECEIVES THE PRODUCT BACK, OR IF ADDITIONAL PERTINENT INFORMATION IS RECEIVED, A FOLLOW-UP MDR REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIACETABULAR OSTEOTOMY PROCEDURE INVOLVING A FEMALE PATIENT, WHEN THE PATIENT'S LEG WAS PLACED DOWN ON THE TABLE, THE AQUAMANTYS 6.0 HAND-HELD DEVICE SLIPPED UNDER THE LEG AND WAS ACTIVATED FOR APPROXIMATELY 5 SECONDS. THE PATIENT REPORTED SUSTAINED AN 8.5 X 4.5CM BURN ON THE LEFT POSTERIOR CALF. THE BURN WAS DESCRIBED AS HAVING BLISTERING AND DISCOLORATION ASSOCIATED WITH A 2ND DEGREE BURN, BUT WAS NOT DIAGNOSED AS A 2ND DEGREE BURN. THE OR DIRECTOR REPORTED TO A TISSUELINK MEDICAL FIELD REPRESENTATIVE THAT THE INCIDENT OCCURRED AS A RESULT OF USER ERROR. THE HOSPITAL REPORTS THAT THEY ARE CONDUCTING THEIR OWN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAMANTYS 6.0 BIPOLAR SEALER AQUAMANTYS BIPOLAR SEALER GEI TISSUELINK MEDICAL, INC. 23-112-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other