BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPULSE-DISPOSBLE PULSE LAVAG SUCTION

    MDR report key: 14191097 · Received April 23, 2022

    Report

    Report Number
    1020279-2022-01924
    Event Type
    Malfunction
    Date Received
    April 23, 2022
    Date of Event
    March 24, 2022
    Report Date
    June 16, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KDC
    UDI-DI
    06951233720279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: THIS EVENT WAS RE-EVALUATED FOR MDR REPORTING. SMITH+NEPHEW DOES NOT HAVE REPORTING RESPONSIBILITIES FOR THIS PRODUCT; THEREFORE, GUANGZHOU, THE LEGAL MANUFACTURER, IS RESPONSIBLE FOR PERFORMING THE REGULATORY ASSESSMENT AND REPORTING TO ANY NCA IF REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHEN OPENING A VERSAPULSE-DISPOSABLE PULSE LAVAG SUCTION BOX DURING THE SET-UP FOR A TKA SURGERY, IT WAS FOUND THAT BOTH STERILE PACKAGING HAD BEEN OPENED ALREADY. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A COMPETITOR'S DEVICE (PULSE LAVAGE FROM ZIMMER - PULSAVAC). PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHEN OPENING A VERSAPULSE-DISPOSBLE PULSE LAVAG SUCTION BOX DURING THE SET-UP FOR A TKA SURGERY, IT WAS FOUND THAT BOTH STERILE PACKAGING HAD BEEN OPENED ALREADY. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A COMPETITOR'S DEVICE (PULSE LAVAGE FROM ZIMMER - PULSAVAC). PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHEN OPENING TWO (2) VERSAPULSE-DISPOSBLE PULSE LAVAG SUCTION BOXES DURING THE SET-UP FOR A TKA SURGERY, IT WAS FOUND THAT BOTH STERILE PACKAGING HAD BEEN OPENED ALREADY. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A COMPETITOR'S DEVICE (PULSE LAVAGE FROM ZIMMER - PULSAVAC). PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705037 VERSAPULSE-DISPOSBLE PULSE LAVAG SUCTION INSTRUMENT, SURGICAL, DISPOSABLE KDC SMITH & NEPHEW, INC. W-203-B(EC) 202112211 06951233720279

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown