BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_ENDOSCOPYPR_PRODUCT

    MDR report key: 7132797 · Received December 20, 2017

    Report

    Report Number
    0002936485-2017-01223
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 21, 2017
    Report Date
    April 6, 2018
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    UNKNOWN PROD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    GTIN-UNKNOWN PRODUCT NUMBER. (B)(4). THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE, IT WILL BE PROVIDED IN FUTURE REPORTS. INVESTIGATION IS ONGOING; ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS IS AN OEM PRODUCT AND IS BEING FILED ON BEHALF OF THE LEGAL MANUFACTURER, BIOCOMPOSITES LTD. GTIN-UNKNOWN PRODUCT NUMBER THE DEVICE MANUFACTURE DATE IS NOT KNOWN, LOT NUMBER NOT PROVIDED. ALLEGED FAILURE: PATIENT INFLAMMATION. PROBABLE ROOT CAUSE: THE OEM OF THE DEVICE COULD NOT PERFORM AN INVESTIGATION WITHOUT THE PHYSICAL DEVICE, THEREFORE A POSSIBLE ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913080 UNKNOWN_ENDOSCOPYPR_PRODUCT UNKNOWN DEVICE KOG STRYKER ENDOSCOPY-SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other