BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIGATOR GRASPER

    MDR report key: 6016582 · Received October 11, 2016

    Report

    Report Number
    3011137372-2016-00296
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OCW
    PMA / PMN Number
    K070686
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DHR FOR LOT ML-000338 WAS REVIEWED FOR TESTING RESULTS. THERE WERE NO DEFECTS FOUND IN 125 SAMPLES THAT WERE INSPECTED FOR VISUAL AND FUNCTIONAL REQUIREMENTS TO (B)(4) SPECIFICATION 14-1- 002481 REVISION 03 AND (B)(4) SPECIFICATION MLT-002 REVISION F. NO SAMPLE WAS PROVIDED FOR REVIEW AND ROOT CAUSE COULD NOT BE DETERMINED. THEREFORE NO CORRECTIVE ACTION OR PREVENTIVE ACTIONS COULD BE ASSIGNED. HOWEVER, MANUFACTURER WILL CONTINUE TO MONITOR AND TREND SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC LAPAROSCOPY THE DISTAL END OF THE DEVICE, THE PART WITH THE TEETH, BROKE OFF INSIDE THE PATIENT. THE LOCATION OF THE BROKEN PART WAS IDENTIFIED VIA X-RAY THEN RETRIEVED WITHOUT INCIDENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC LAPAROSCOPY THE DISTAL END OF THE DEVICE, THE PART WITH THE TEETH, BROKE OFF INSIDE THE PATIENT. THE LOCATION OF THE BROKEN PART WAS IDENTIFIED VIA X-RAY THEN RETRIEVED WITHOUT INCIDENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669030 ALLIGATOR GRASPER ENDOSCOPE AND/OR ACCESSORIES OCW TELEFLEX MEDICAL ML-000338

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention