BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTO-LOK ATRA ALLIS FCP 3.5X24

    MDR report key: 6125575 · Received November 23, 2016

    Report

    Report Number
    2523190-2016-00196
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 3, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GCJ
    PMA / PMN Number
    K941541
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/22/2016 . THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. RESULTS: DHR REVIEW. NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THERE WAS FORCEPS, MANUFACTURED IN DECEMBER 2014, RETURNED USED/PROCESSED FORCEPS SHOWING WEAR, AND BROKEN AT TIP. THE COMPLAINT REPORT HAS BEEN CONFIRMED; THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY. .

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THAT DURING THE COURSE OF A ROBOTIC LAPAROSCOPIC NISSAN RETRACTION WAS NEEDED. AN ATRAU-ALLIS GRASPING FORCEPS WAS INSERTED AND CLAMPED TO PROVIDE THE RETRACTION NEEDED. AT THIS POINT THE INSTRUMENT SEEMED TO BE IN GOOD WORKING ORDER. AS THE PROCEDURE PROGRESSED AND THE RETRACTION NEEDS CHANGED THE INSTRUMENT WAS REPOSITIONED AND AT THIS TIME WAS NOTED BY THE SURGEON THAT THE INSTRUMENT HAD BROKEN. UNDER DIRECT LAPAROSCOPIC VISION IT WAS NOTICED THAT THE INSTRUMENT HAD A PORTION OF WHAT APPEARED TO BE THE GRASPING LINKAGE THAT HAD BROKEN. SOME MANIPULATION WAS DONE TO THE INSTRUMENT TO REMOVE IT FROM THE TROCAR AND IT WAS INSPECTED ONCE OUTSIDE OF THE BODY. AFTER THE CASE HAD FINISHED THE PATIENT WAS X-RAYED AND RADIOLOGY NOTED A 2 MM RADIODENSITY WITHIN THE ABDOMEN THAT MAY REPRESENT A RETAINED FOREIGN BODY. THIS WAS RELAYED TO THE SURGEON WHO INDICATED THAT IT WOULD BE EXTREMELY DIFFICULT TO LOCATE THE REMNANT GIVEN ITS SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775896 ROTO-LOK ATRA ALLIS FCP 3.5X24 3.5MM ENDOSCOPIC INSTRUMENTATION GCJ INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other