BEUDAMED
    FDA Adverse Event Death Summary report: N

    PINPOINT LAPAROSCOPE - 10MM, STANDARD, 30 WITH WOLF AND STORZ ADAPTOR

    MDR report key: 10532266 · Received September 14, 2020

    Report

    Report Number
    3012345110-2020-00006
    Event Type
    Death
    Date Received
    September 14, 2020
    Date of Event
    August 19, 2020
    Report Date
    October 27, 2020
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    PMA / PMN Number
    K150956
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE MANUFACTURE DATE IS NOT KNOWN. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: "NONE OF THE PRODUCTS ARE DEFECTIVE / FAULTY OR WERE INVOLVED AT THE TIME OF DEATH. PATIENT DIED DURING OPEN COLON INTERPOSITION SURGERY. PRODUCTS WERE PLACED IN THE THORAX ONLY TO ILLUMINATE. DURING THE SURGERY, THE LIGHT GUIDE CABLE, LENS AND CAMERA WERE USED TO ILLUMINATE DEEPER INTO THE PATIENT'S OPEN THORAX (TO HELP THE DOCTORS SEE BETTER). THE DEVICES ARE DEMO GOODS FROM OUR SALES REP. OUR SALES REP WAS PRESENT DURING THE SURGERY." PROBABLE ROOT CAUSE: ACCORDING THE CUSTOMER PROVIDED EVENT DESCRIPTION, NO FAILURE OR MALFUNCTION WAS ASSOCIATED WITH THE PINPOINT SYSTEM. THE PATIENT DEATH WHICH OCCURRED DURING THE CASE WAS A SEPARATE ISSUE NOT RELATED TO ANY OF THE PINPOINT DEVICES. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. H3 OTHER TEXT: 81.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS PATIENT DEATH. PLEASE NOTE THAT THERE IS NO ALLEGED DEFICIENCY WITH THE REPORTED DEVICES AND IT CANNOT BE DETERMINED AT THIS TIME, WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PATIENT DEATH. PLEASE NOTE THAT THERE IS NO ALLEGED DEFICIENCY WITH THE REPORTED DEVICES AND IT CANNOT BE DETERMINED AT THIS TIME, WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991643 PINPOINT LAPAROSCOPE - 10MM, STANDARD, 30 WITH WOLF AND STORZ ADAPTOR LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death