BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAW FORCEPS, SPRING-LOADED, 10MM, 32CM

    MDR report key: 1420126 · Received April 16, 2009

    Report

    Report Number
    2430952-2009-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2009
    Report Date
    April 14, 2009
    Manufacturer
    TONTARRA MEDIZINTECHNIK GMBH
    Product Code
    GEN
    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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORP (B)(4). ATTENTION: CORPORATE COMPLAINTS COORDINATOR.

    Description of Event or Problem · 1

    DURING THE SURGERY, THE INSTRUMENT SEIZED. THERE WAS NO PT INJURY. ADDITIONAL INFORMATION PROVIDED BY THE DEALER ON (B)(6) 2009, FROM THE USER, INDICATES THAT THE DEVICE SEIZED 10-15 MINUTES INTO THE PROCEDURE WHILE INSIDE THE PT. THEY FURTHER REPORTED THAT NO METAL PIECE WAS FOUND IN THE PT, WHICH WAS CONFIRMED BY AN X-RAY. THE PT WAS INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAW FORCEPS, SPRING-LOADED, 10MM, 32CM ENDOSCOPIC INSTRUMENTATION GEN TONTARRA MEDIZINTECHNIK GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1