BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CWIII ARTHROSCOPY PUMP

    MDR report key: 16831392 · Received April 28, 2023

    Report

    Report Number
    1220246-2023-06598
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    March 14, 2023
    Report Date
    April 28, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867039346
    PMA / PMN Number
    K024291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DEVICE DIDN`T TURN OFF AND WATER RAN OVER THE PATIENT'S FOOT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 20-MAR-2023. IT WAS CONFIRMED THAT THE TUBING AR-6420 (LOT: Z2004) WAS USED WHEN THE ERROR OCCURRED. UPDATE AVOE 29-MAR-2023. FURTHER INFORMATION WAS PROVIDED REGARDING A PATIENT INJURY THAT OCCURRED DURING THE INCIDENT. DURING THE OPERATION, THE PUMP FILLED THE PATIENT'S LEG WITH FLUID. THIS CONSIDERABLY INCREASED THE CIRCUMFERENCE OF THE LEG. AFTER THIS INCIDENT, THE PUMP WAS TAKEN OUT OF SERVICE AND STORED IN THE MEDICAL TECHNOLOGY OFFICE. UPDATE AVOE 04-APR-2023. FURTHER INFORMATION WAS REQUESTED AND PROVIDED THAT THE PATIENT WAS ADMITTED AS AN INPATIENT FOR ONE NIGHT FOR MONITORING. THE PATIENT WAS TREATED WITH LYMPHATIC DRAINAGE IN THE RECOVERY ROOM, THE LEG WAS ELEVATED IN A SPLINT AND WRAPPED. THERE WAS A CLEAR IMPROVEMENT IN HIS CONDITION. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477153 CWIII ARTHROSCOPY PUMP ARTHROSCOPE AND ACCESSORIES HRX ARTHREX, INC. CWIII ARTHROSCOPY PUMP 00888867039346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R| H