BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPULSE HANDPIECE WITH HIGH FLOW TIP

    MDR report key: 1242306 · Received November 19, 2008

    Report

    Report Number
    2648666-2008-00141
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 31, 2008
    Report Date
    October 31, 2008
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS NOT RETURNED TO THE MANUFACTURER. IT WAS REPORTED THAT THE BATTERY PACK HAD BEEN IMMERSED IN SALINE DURING THE SURGERY, CONTRARY TO THE WARNING IN THE INSTRUCTIONS FOR USE. ACCORDING TO THE QUALITY ENGINEER, IF FOR ANY REASON SALINE SOLUTION ENTERS THE BATTERY PACK, A CHEMICAL REACTION OCCURS CAUSING THE BATTERIES TO DECOMPOSE. IF THIS OCCURS, THE BATTERY ACID IS MIXED WITH THE SALINE WATER RESULTING IN A BROWN-BLACK COLOR. BASED ON THIS INFORMATION, IT WAS DETERMINED THAT THE CONDITION WAS CAUSED BY USER MISUSE. THE INSTRUCTIONS FOR USE INCLUDE A WARNING THAT STATES POWER PACKS CANNOT BE IMMERSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE JOINT REPLACEMENT SURGERY, BLACK FLUID FROM THE BATTERY PACK SPOUTED INTO THE SURGICAL SITE. A REVISION SURGERY WAS PERFORMED AFTER THE BONE WAS CUT TO REMOVE THE BLACK SPOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPULSE HANDPIECE WITH HIGH FLOW TIP JET LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO 08260012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention