BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPY-PHI DRUG DRAPE KIT

    MDR report key: 7737479 · Received July 31, 2018

    Report

    Report Number
    3012345110-2018-00006
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    June 14, 2017
    Report Date
    December 2, 2020
    Manufacturer
    NOVADAQ TECHNOLOGIES
    Product Code
    MMP
    PMA / PMN Number
    K041501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION WAS COMPLETED BY NOVADAQ TECHNOLOGIES, INC. PRIOR TO THEIR ACQUISITION BY STRYKER. THE INVESTIGATIONS WERE COMPLETED TO NOVADAQ'S ACTIVE PROCEDURE AT THAT TIME, QSP 8.2-1 REV E, CUSTOMER FEEDBACK & COMPLAINT HANDLING. SEE ATTACHED INVESTIGATION 17-CR-218. THIS COMPLAINT WAS TRANSFERRED TO TRACKWISE TO FILE AN MDR AS PART OF REMEDIATION ACTIVITIES AND THEREFORE WILL NOT UNDERGO AN INVESTIGATION PER DWI2508.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PINHOLE LEAKS WERE FOUND IN THE DRAPE. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    NOVADAQ TECHNOLOGIES, INC. WAS ACQUIRED BY STRYKER. THIS MDR IS BEING SUBMITTED LATE BECAUSE IT WAS IDENTIFIED DURING THE INTEGRATION AND REMEDIATION ACTIVITIES INITIATED BY STRYKER ENDOSCOPY IN CONJUNCTION WITH THIS ACQUISITION. THE SPY-PHI DRAPE IS A STERILE, SINGLE USE DRAPE INTENDED TO BE PLACED OVER THE SPY-PHI DEVICE AND PROVIDE A STERILE BARRIER OF THE IMAGING HEAD SO THAT THE SPY-PHI DEVICE CAN BE USED IN THE STERILE OPERATING ENVIRONMENT. THE SPY-PHI DEVICE ITSELF IS INTENDED TO BE USED AT A WORKING DISTANCE OF ¿10 TO 40 CM (4 TO 15 INCHES) FROM THE SURFACE OR TISSUE TO BE IMAGED¿ IN ACCORDANCE WITH PG. 58 OF THE SPY-PHI OPERATOR¿S MANUAL. THE BREACH IN THE DRAPE MATERIAL WAS OBSERVED AFTER THE DEVICE WAS INSERTED INTO THE BREAST POCKET OF A PATIENT BY THE OPERATING SURGEON. TO DATE, NOVADAQ HAS NOT RECEIVED ANY REPORTS OF PATIENT INJURY OR INFECTION AS A RESULT OF HH2000 DRAPE STERILE BARRIER FAILURE. THIS EVENT WAS INITIALLY REPORTED UNDER THE ASSOCIATED RECALL Z-3236-2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PINHOLE LEAKS WERE FOUND IN THE DRAPE. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576620 SPY-PHI DRUG DRAPE KIT COVER, BARRIER, PROTECTIVE MMP NOVADAQ TECHNOLOGIES 1704F

    Patients

    Seq Age Sex Outcome Treatment
    1