BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, 5MM INSERT, 45CM, DEBAKEY FORCEPS

    MDR report key: 8190651 · Received December 21, 2018

    Report

    Report Number
    0002936485-2018-00727
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 4, 2018
    Report Date
    May 10, 2019
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OCZ
    UDI-DI
    07613327056501
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: DURING A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED BY DR. PRIMOMO, ONE OF OUR STRYKER DEBAKEY INSERTS (CAT #: 250-080-748 LOT #1246159) BROKE WHILE BEING USED ON A PATIENT. I BELIEVE THAT THE CAUSE OF THE MALFUNCTION WAS THAT THE SCREW THAT CONNECTS THE JAWS AT THE DISTAL TIP, BECAME DISCONNECTED TO ONE SIDE OF THE JAWS. THE SCREW IS STILL ATTACHED TO THE OTHER SIDE OF THE JAW THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES COULD BE EXCESSIVE FORCE, OR ROTATIONAL FORCE WITH THE JAW UNDER LOAD. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURER DATE IS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION CONFIRMED THAT NO BROKEN PIECESWERE LEFT INSIDE THE PATIENT.

    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 THE DEVICE BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION CONFIRMED THAT NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031696 PKG, 5MM INSERT, 45CM, DEBAKEY FORCEPS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED OCZ STRYKER ENDOSCOPY-SAN JOSE 1246159 07613327056501

    Patients

    Seq Age Sex Outcome Treatment
    1