BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN SURGICAL

    MDR report key: 8557895 · Received April 26, 2019

    Report

    Report Number
    1423395-2019-00013
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    February 21, 2019
    Report Date
    April 26, 2019
    Manufacturer
    ASPEM 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 THE POST-OPERATIVE X-RAY REVEALED THAT THE #11 BLADE (FROM THE CUSTOM ORTHOPEDIC TRAY) WAS RETAINED IN PATIENT'S LEFT SHOULDER. PER REPORT, ON (B)(6) 2019, PATIENT UNDERWENT LEFT SHOULDER ARTHROSCOPY, LABRAL REPAIR WITH CAPSULORRPHAPHY, AND CYST DECOMPRESSION. 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. REPORTEDLY, THE PATIENT WAS DISCHARGED TO HOME THE SAME DAY. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR A SYNCOPAL EPISODE. THE PATIENT WAS ALSO REPORTEDLY HAVING POST-OPERATIVE SHOULDER PAIN AT THAT TIME. THE PATIENT WAS DISCHARGED TO HOME AND WAS TOLD TO FOLLOW-UP WITH HIS PRIMARY CARE PHYSICIAN IN TWO DAYS. PER REPORT, THE PATIENT WENT TO SEE HIS SURGEON FOR FOLLOW-UP AND SURGEON ORDERED THE LEFT SHOULDER X-RAY, WHICH SHOWED THE RETAINED BLADE. IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO ANOTHER FACILITY FOR THE RETAINED BLADE TO BE RETRIEVED. THE PATIENT REPORTEDLY RECOVERED FROM THE RETRIEVAL OPERATION WITH NO FURTHER ADVERSE EFFECTS. DUE TO THE REPORTED EVENT AND REQUIRED MEDICAL INTERVENTION TO RETRIEVE THE RETAINED DEVICE, 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 THE POST-OPERATIVE X-RAY REVEALED THAT THE #11 BLADE (FROM THE CUSTOM SURGICAL TRAY) WAS RETAINED IN PATIENT'S LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349923 ASPEN SURGICAL SURGICAL BLADE FROM CUSTOM ORTHO SHOULDER SCOPE TRAY OJH ASPEM SURGICAL UNK 10889942689866

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention