BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE

    MDR report key: 5352481 · Received January 7, 2016

    Report

    Report Number
    0002936485-2016-00038
    Event Type
    Injury
    Date Received
    January 7, 2016
    Date of Event
    December 17, 2015
    Report Date
    December 21, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FCW
    PMA / PMN Number
    K082813
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: SAFELIGHT DESIGN; BOOT MATERIAL; LIGHT SOURCE ((B)(4) WHITE LIGHT OUTPUT); USE ERROR. ¿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 BY DR. (B)(6), SURGEON OF THE HOSPITAL, THAT HE WAS PERFORMING A LAPAROSCOPIC INTERVENTION BY USING A STRYKER TOWER. AFTER 2 HOURS SURGERY TIME HE STORED THE CONNECTED 1488 CAMERA HEAD WITH A 5MM PROBE (FOREIGN PROBE EMOS) AND CONNECTED STRYKER LIGHT CABLE WITH A SWITCHED ON STRYKER LED LIGHT SOURCE FOR 5-10 MINUTES ONTO THE UPPER ABDOMEN OF THE PATIENT. THE LIGHT SOURCE WAS UP TO 80%. AFTER REMOVAL OF THE BLANKET A SMALL OVAL ERYTHEMA (BURN) ON THE LEFT UPPER ABDOMEN OF THE PATIENT WAS OBSERVED. THE REASON FOR THIS WAS THE HEATED METAL AT THE ADAPTER BETWEEN SCOPE AND LIGHT CABLE. THE PATIENT WAS TREATED WITH SALVE AND BANDAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY DR. (B)(6), SURGEON OF THE HOSPITAL, THAT HE WAS PERFORMING A LAPAROSCOPIC INTERVENTION BY USING A STRYKER TOWER. AFTER 2 HOURS SURGERY TIME HE STORED THE CONNECTED 1488 CAMERA HEAD WITH A 5MM PROBE (FOREIGN PROBE EMOS) AND CONNECTED STRYKER LIGHT CABLE WITH A SWITCHED ON STRYKER LED LIGHT SOURCE FOR 5-10 MINUTES ONTO THE UPPER ABDOMEN OF THE PATIENT. THE LIGHT SOURCE WAS UP TO 80 %. AFTER REMOVAL OF THE BLANKET A SMALL OVAL ERYTHEMA (BURN) ON THE LEFT UPPER ABDOMEN OF THE PATIENT WAS OBSERVED. THE REASON FOR THIS WAS THE HEATED METAL AT THE ADAPTER BETWEEN SCOPE AND LIGHT CABLE. THE PATIENT WAS TREATED WITH SALVE AND BANDAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9436 5.0MM X 10FT CLEAR CASE FIBEROPTIC LIGHT CABLE LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW STRYKER ENDOSCOPY-SAN JOSE 111121

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other