BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN SURGICAL

    MDR report key: 8557667 · Received April 26, 2019

    Report

    Report Number
    1423395-2019-00011
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    March 26, 2019
    Report Date
    April 26, 2019
    Manufacturer
    ASPEN SURGICAL
    Product Code
    OJH
    UDI-DI
    10889942689866
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WHILE SURGEON WAS MAKING A SKIN INCISION DURING A SHOULDER ARTHROSCOPY, THE #11 SURGICAL BLADE (TAKEN FROM CUSTOM ORTHOPEDIC PACK) BROKE. REPORTEDLY, ALL OF THE BLADE'S BROKEN PIECES WERE SUCCESSFULLY RETRIEVED THROUGH AN UNIDENTIFIED METHOD. IT IS UNKNOWN IF ANY ISSUE WAS NOTED WITH THE SURGICAL BLADE DURING INSPECTION PRIOR TO USE AND WHETHER ANY EXCESSIVE FORCE WAS APPLIED TO OR AGAINST THE BLADE DURING USE. NO IMPACT TO THE PATIENT, THE STAFF, THE PROCEDURE, OR THE TOTAL LENGTH OF THE PROCEDURE WAS REPORTED. PER REPORT, THE PATIENT WAS DISCHARGED THE SAME DAY AND IS APPROPRIATELY RECOVERING AT THIS TIME. DUE TO THE REPORTED EVENT AND MEDICAL INTERVENTION REQUIRED TO RETRIEVE THE BROKEN PIECES OF THE SURGICAL BLADE, THIS MEDWATCH IS BEING FILED. THE SAMPLE HAS BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE MANUFACTURER OF THE SURGICAL BLADE HAS BEEN NOTIFIED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SURGEON WAS MAKING A SKIN INCISION DURING A SHOULDER ARTHROSCOPY, THE #11 SURGICAL BLADE (TAKEN FROM CUSTOM ORTHOPEDIC PACK) BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348900 ASPEN SURGICAL SURGICAL BLADE IN CUSTOM ORTHO SHOULDER SCOPE TRAY OJH ASPEN SURGICAL UNK 10889942689866

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention