BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRPLS HP W/BO CLEAN TIP S-TB

    MDR report key: 3477611 · Received November 19, 2013

    Report

    Report Number
    0001811755-2013-02907
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    October 22, 2013
    Report Date
    October 23, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON EVENT DESCRIPTION, THE REPORTED ¿BATTERIES ASSEMBLED IN WRONG WAY¿ WAS OBSERVED ¿WHEN REMOVING THE BATTERIES, FOLLOWING SURGERY¿, AFTER PROCEDURE COMPLETION. NO PRODUCT MALFUNCTION CONDITION WAS REPORTED DURING USAGE. NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION AND NO SURGICAL DELAY WERE REPORTED. THE FOLLOWING NOTES / WARNINGS ARE INCLUDED IN PRODUCT IFU (B)(4): ALWAYS FOLLOW THE CURRENT LOCAL RECOMMENDATIONS AND/OR REGULATIONS GOVERNING ENVIRONMENTAL PROTECTION AND RISKS ASSOCIATED WITH RECYCLING OR DISPOSING OF THE EQUIPMENT AT THE END OF ITS USEFUL LIFE. ALWAYS DECONTAMINATE EQUIPMENT AND BATTERIES EXPOSED TO INFECTIOUS MATERIAL BEFORE SENDING THEM TO A WASTE TREATMENT FACILITY. PER THE EUROPEAN COMMUNITY (EC) WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT (WEEE) DIRECTIVE 2002/96/EC, PRODUCT MUST BE COLLECTED SEPARATELY. DO NOT DISPOSE OF AS UNSORTED MUNICIPAL WASTE. CONTACT LOCAL DISTRIBUTOR FOR DISPOSAL INFORMATION. TO COMPLY WITH THE EC BATTERY DIRECTIVE 2006/66/EC, THIS DEVICE HAS BEEN DESIGNED FOR SAFE REMOVAL OF BATTERIES AT END OF LIFE BY THE END USER USING THE INSTRUCTIONS PROVIDED HEREIN. DO NOT REMOVE THE BATTERIES IN THE PRESENCE OF A PATIENT. DO NOT CUT THE IRRIGATION TUBING/POWER CORD TO REMOVE THE BATTERY POWER PACK FROM THE HANDPIECE. FAILURE TO COMPLY MAY CAUSE ELECTRICAL SHOCK, EXCESSIVE HEAT AND/OR SPARKS AND RESULT IN INJURY AND/OR FIRE. BATTERY REMOVAL INSTRUCTIONS: PUSH THE TWO BATTERY LID REMOVAL TABS AND REMOVE THE LID FROM THE BATTERY POWER PACK HOUSING. REMOVE THE BATTERY HOLDER FROM THE BATTERY HOUSING. REMOVE THE EIGHT AA BATTERIES. RECYCLE OR DISPOSE OF THE BATTERIES AND EQUIPMENT PROPERLY. THEREFORE, SINCE NO PRODUCT MALFUNCTION WAS REPORTED AND BASED ON MANUFACTURING INSTRUCTIONS BATTERIES WERE PROPERLY ASSEMBLED THERE IS NO PRODUCT / DEVICE FAILURE. CUSTOMER DISCARDED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED. DEVICE NOT YET RECEIVED BY MANUFACTURER

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE INTERPULSE BATTERIES FOLLOWING A PROCEDURE THE BATTERIES WERE OBSERVED TO BE IN THE WRONG WAY AROUND. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL OF THE INTERPULSE BATTERIES FOLLOWING A PROCEDURE, THE BATTERIES WERE OBSERVED TO BE IN THE WRONG WAY AROUND. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598402 INRPLS HP W/BO CLEAN TIP S-TB LAVAGE, JET FQH STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1