BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPULSE PLUS SYSTEM

    MDR report key: 31840 · Received February 7, 1996

    Report

    Report Number
    31840
    Event Type
    Other
    Date Received
    February 7, 1996
    Date of Event
    January 15, 1996
    Report Date
    January 23, 1996
    Manufacturer
    DAVOL, INC.
    Product Code
    FQH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING TOTAL HIP REPLACEMENT, FEMORAL REAMING TO ACCEPT PROSTHESIS, SUCTIONING DOWN FEMUR WITH FEMORAL TIP. SCRUB NURSE OBSERVED SUCTION TIP MISSING FOLLOWING SUCTION. SEARCH ENSUED OF FIELD, TRASH ETC - NEGATIVE. SURGEON REMOVED BONE PLUG TO EXAMINE SHAFT TO VALIDATE TIP NOT LODGED IN CHANNEL - NEGATIVE. EXTENDED SURGICAL PROCEDURE BY 45 MIN. X-RAY PROCEDURES PERFORMED TO VISUALIZE - NEGATIVE. MFR NOTIFIED. SUBSTITUTE PRODUCT ORDERED FOR SIMILAR PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPULSE PLUS SYSTEM SURGICAL SUCTION DEVICE FQH DAVOL, INC. 21EF4077/211F4026

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other