BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWS "HIQ+", 5 X 330 MM, JOHANN LONG

    MDR report key: 6749996 · Received July 28, 2017

    Report

    Report Number
    9610773-2017-00095
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    July 4, 2017
    Report Date
    August 23, 2017
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCJ
    PMA / PMN Number
    PK944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), (B)(4) (RETURNED TO OMSC ON 2017-07-13). THE EVALUATION/INVESTIGATION CONFIRMED THAT ONE OF THE GRASPING FORCEPS' JAWS IS BROKEN OFF. THE CAUSE OF THIS DAMAGE AND THE BREAKAGE OF THE JAW IS MOST LIKELY MECHANICAL OVERLOAD BY THE APPLICATION OF EXCESSIVE FORCE. THEREFORE, THIS EVENT/INCIDENT WAS ATTRIBUTED TO USE ERROR. FURTHERMORE, A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE GRASPING FORCEPS WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED FROM OSTE SIDE WITH NO FURTHER ACTIONS BUT THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS AND RETRAINED TO CORRECTLY USE THE OLYMPUS MEDICAL DEVICES.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), (B)(4)(RETURNED TO OMSC ON 2017-07-13). HOWEVER, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED YET SINCE THE EVALUATION/INVESTIGATION IS STILL ONGOING. AS SOON AS THE INVESTIGATION RESULTS AND FINAL EVALUATION ARE AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC-ASSISTED COLECTOMY PROCEDURE, THE JAWS OF THE GRASPING FORCEPS BROKE AND A FRAGMENT FELL INSIDE THE PATIENT'S BODY CAVITY. HOWEVER, NO FRAGMENT REMAINED INSIDE THE PATIENT SINCE IT WAS REPORTEDLY RETRIEVED. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY. POST PROCEDURE, AN EXAMINATION BY X-RAY SHOWED NO FOREIGN OBJECTS INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530422 JAWS "HIQ+", 5 X 330 MM, JOHANN LONG HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR (HANDLES, SHAFTS, JAWS INSERTS GCJ OLYMPUS WINTER & IBE GMBH WA64130A 122W

    Patients

    Seq Age Sex Outcome Treatment
    1