BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGATOR GRASPER

    MDR report key: 4360660 · Received December 19, 2014

    Report

    Report Number
    9611102-2014-00011
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    September 11, 2014
    Report Date
    November 7, 2014
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION ON THE ACTUAL DEVICE WAS COMPLETED AS IT WAS NOT RETURNED. HOWEVER, PHOTOS OF THE DEVICE WERE RECEIVED ON 11/21/2014. AFTER FOLLOW-UP WITH FACILITY ACTUAL DEVICE IS BEING SENT IN FOR INVESTIGATION. DEVICE CURRENTLY IN TRANSIT TO (B)(4) FOR INVESTIGATION. (B)(4) CONSIDERS THIS MATTER OPENED. AFTER INVESTIGATION IS COMPLETED, WE WILL PROVIDE FDA WITH FOLLOWING-UP INFORMATION.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENTS (B)(4) WAS NOTIFIED BY RICHARD WOLF MEDICAL INSTRUMENTS CORP. (B)(4) OUR DISTRIBUTOR, OF THE FOLLOWING INCIDENT: DURING A LAPAROSCOPIC ROBOTIC-ASSISTED PARTIAL NEPRECTOMY PROCEDURE, THE HINGE OF THE DEVICE CAME APART AND ONE SIDE OF THE JAW FELL INSIDE OF PATIENT. FOREIGN OBJECT WAS OUT OF THE FIELD OF VIEW OF THE SURGEON AND AFTER 20 MINUTES OF EXPLORATION, WITH FLUOROSCOPY AND X-RAY, FOREIGN OBJECT WAS NOT FOUND. SURGEON MADE THE DECISION TO LEAVE THE FOREIGN OBJECT IN THE PLACE RATHER THAN RISK A CONTINUED SEARCH AND POSSIBLE BOWEL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836134 ALIGATOR GRASPER FORCEPS GCJ RICHARD WOLF GMBH 83934156

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR