BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE LOCK TENACULUM FORCEPS 5MM 32CM

    MDR report key: 1421268 · Received April 22, 2009

    Report

    Report Number
    2430952-2009-00004
    Event Type
    Malfunction
    Date Received
    April 22, 2009
    Report Date
    April 22, 2009
    Manufacturer
    KOSCHER & WUERTZ GMBH
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS USED FOR THE FIRST TIME AND IT SNAPPED. THE DEVICE HAD PATIENT CONTACT, NO PATIENT INJURY REPORTED. IT WAS REPORTED TO THE DEALER REPRESENTATIVE, BY THE HOSPITAL, THAT A LAPAROSCOPIC HYSTERECTOMY WAS IN PROGRESS WHEN ON SIDE OF THE GRASPER BROKE OFF IN THE ABDOMEN. THE PIECE OF THE INSTRUMENT WAS EASILY RECOVERED, AND THERE WAS NO SIGNIFICANT DELAY AND NO HARM TO THE PATIENT. THE BROKEN PIECE WAS RETURNED TO JARIT WITH THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIDE LOCK TENACULUM FORCEPS 5MM 32CM NA GEN KOSCHER & WUERTZ GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1