BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING FORCEPS, RATCHET, 3.5MM, 24CM

    MDR report key: 1064443 · Received June 12, 2008

    Report

    Report Number
    2430952-2008-00017
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 12, 2008
    Manufacturer
    KOSCHER & WUERTZ GMBH
    Product Code
    HTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR J. JAMMER SURGICAL INSTRUMENTS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN OPERATION THE HINGE PINE FROM THE GRASPING FORCEPS CAME OFF AND DROPPED INTO THE PT'S CAVITY. THE HINGE PINE AND A SMALL METAL PIECE WERE REMOVED FROM THE PT. BASED UPON THE SUPPLIED PHOTOGRAPHS OF THE PIN AND METAL PIECE, ALL THE PIECES SHOULD HAVE BEEN ACCOUNTED FOR. HOWEVER, THERE WAS NO INFO INDICATING AN X-RAY WAS PERFORMED. THERE WAS NO REPORTED INJURY. ON 6/9/08, ADDITIONAL INFO - IT WAS REPORTED BY THE (B) (4) DISTRIBUTOR THAT THEY COULD ONLY CONFIRM THE DEVICE WAS USED DURING A LAPAROSCOPIC PROCEDURE IN THE ABDOMINAL CAVITY, NO SPECIFIC INFO WAS AVAILABLE FROM THE HEALTHCARE FACILITY. THE SURGEON CONFIRMED THAT AN X-RAY EXAMINATION PROVED BEYOND DOUBT THAT NO PART OF THE DEVICE WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRASPING FORCEPS, RATCHET, 3.5MM, 24CM JARIT ENDOSCOPIC INSTRUMENT HTD KOSCHER & WUERTZ GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1