BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET EXACT ASSY, 15 DEGREE X 14MM

    MDR report key: 11580364 · Received March 28, 2021

    Report

    Report Number
    8043484-2021-00691
    Event Type
    Malfunction
    Date Received
    March 28, 2021
    Date of Event
    March 3, 2021
    Report Date
    October 18, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQH
    UDI-DI
    40565126630
    PMA / PMN Number
    K143115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THE VISUAL EVALUATION FOUND NO ISSUES. THE FUNCTIONAL EVALUATION FOUND THE DEVICE FAILED TO PRIME, ESTABLISHING A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT. THE ROOT CAUSE WAS IDENTIFIED AS A COMPONENT FAILURE. A REVIEW OF THE MANUFACTURING RECORDS FOUND THAT THERE WAS NO EVIDENCE THAT THE PRODUCT DIDN¿T MEET SPECIFICATIONS AT THE TIME OF MANUFACTURE. A COMPLAINT HISTORY REVIEW FOUND FURTHER INSTANCES OF THE REPORTED EVENT. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Additional Manufacturer Narrative · 1

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. ALL PROVIDED INFORMATION HAS BEEN REVIEWED AND WE HAVE NOT BEEN ABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT OR DETERMINE A ROOT CAUSE. PROBABLE ROOT CAUSE MAY INCLUDE KINKS, LEAKS OR BLOCKAGES, OR A COMPONENT FAILURE. NO LOT/SERIAL NUMBER HAS BEEN PROVIDED, THEREFORE A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE. A COMPLAINT HISTORY REVIEW FOUND FURTHER INSTANCES OF THE REPORTED EVENT. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALINE STOPPED FLOWING DURING WOUND RESECTION SURGERY. TREATMENT WAS CONTINUED WITH A BACKUP DEVICE. THERE IS NO HARM TO THE PATIENT. THERE IS NO DELAY IN TREATMENT. THE HANDPIECE WILL BE RETURNED TO OKC IF NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING WOUND RESECTION SURGERY, THE SALINE STOPPED FLOWING FROM THE VERSAJET EXACT ASSY, 15 DEGREE X 14MM. TREATMENT WAS CONTINUED WITH A BACK-UP DEVICE WITHOUT ANY DELAY. PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477664 VERSAJET EXACT ASSY, 15 DEGREE X 14MM LAVAGE, JET FQH SMITH & NEPHEW MEDICAL LTD. 50854630 40565126630

    Patients

    Seq Age Sex Outcome Treatment
    1