BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPY-PHI DRAPES ONLY (PACK OF 20)

    MDR report key: 11369243 · Received February 23, 2021

    Report

    Report Number
    0002936485-2021-00106
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    January 26, 2021
    Report Date
    April 27, 2021
    Manufacturer
    NOVADAQ TECHNOLOGIES
    Product Code
    MMP
    UDI-DI
    10858701006329
    PMA / PMN Number
    K041501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: "ONE OF THE RUBBER BAND WAS MISSING DURING PROCEDURE, AND THEY WANT TO KNOW WHETHER IT CAN BE DETECTED BY X-RAY OR NOT. IT WAS USED DURING OPEN SURGERY FOR LIVER. THEY ALSO WANT TO KNOW THE BIOCOMPATIBILITY OF THE RUBBER.". PROBABLE ROOT CAUSE(S): PRODUCT WAS NOT RECEIVED IN-HOUSE AT STRYKER ENDOSCOPY. BIOCOMPATIBILITY DATA FOR THE RUBBER BAND IS UNAVAILABLE AS THIS COMPONENT IT IS NOT INTENDED AS A PATIENT-CONTACTING PART. TESTING BY STRYKER REP IN CONJUNCTION WITH HOSPITAL STAFF FOUND THAT THE RUBBER BAND COULD BE VISUALIZED VIA X-RAY UNDER AN IN-VITRO SETTING. HOWEVER, ROOT CAUSE OF ISSUE CANNOT BE DETERMINED AS IT IS UNKNOWN AS TO WHETHER THE RUBBER BAND BROKE OR WAS ACCIDENTALLY DISLODGED DURING HANDLING OF CAMERA. IN ADDITION, THERE WERE NO UPDATES AS TO WHETHER THE RUBBER BAND WAS FOUND INSIDE THE PATIENT, NECESSITATING MEDICAL INTERVENTION. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED. IN THE EVENT THAT THE DEVICE IS RETURNED OR ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A RUBBER BAND POTENTIALLY REMAINS INSIDE THE PATIENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RUBBER BAND POTENTIALLY REMAINS INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266410 SPY-PHI DRAPES ONLY (PACK OF 20) COVER, BARRIER, PROTECTIVE MMP NOVADAQ TECHNOLOGIES NR 10858701006329

    Patients

    Seq Age Sex Outcome Treatment
    1 Other