BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANA PERINEAL POST

    MDR report key: 5644901 · Received May 10, 2016

    Report

    Report Number
    2921578-2016-00009
    Event Type
    Injury
    Date Received
    May 10, 2016
    Report Date
    August 30, 2016
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON USER, IS UNCLEAR ON WHAT PERINEAL POSTS HE HAS USED WITH THE HANA TABLE. ACCORDING TO THE FACILITY PREVIOUSLY USED THE SMITH & NEPHEW PERINEAL POST, ALTHOUGH IT IS UNCLEAR IF WAS USED WITH THE HANA TABLE OFF-LABEL. SINCE THE INCEPTION OF THEIR USE OF MIZUHO OSI 6" DIAMETER PERINEAL POST, THE SURGEON HAS SEEN AN INCREASE IN INCIDENCE OF TEMPORARY NERVE PALSY. DOCTOR CLAIMS THAT PREVIOUSLY HE ALSO HAD AN INCIDENCE OF TEMPORARY NERVE PALSY. THE SIZE OF HIS PATIENTS HAS NOT CHANGED, AND HIS SURGICAL CASE LENGTH IS CONSISTENT WITH THE PAST. HE HAS BEGUN TO WRAP THE POSY WITH WEBRIL FOLLOWING THE PATIENT INCIDENT. DOCTOR HAS MADE THIS CHANGE ON HIS OWN ACCORD. MIZUHO OSI CLINICAL MARKETING SPECIALIST ME WITH THE FACILITY'S STAFF TO REVIEW AND CONFIRM THEIR AWARENESS OF THE RISK ASSOCIATED WITH THIS PROCEDURE ((B)(6) 2016). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT HAD NERVE DAMAGE AFTER HIP ARTHOSCOPY.

    Description of Event or Problem · 1

    PATIENT HAD NERVE DAMAGE AFTER HIP ARTHOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298147 HANA PERINEAL POST TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 6850-413

    Patients

    Seq Age Sex Outcome Treatment
    1 Other