BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT ENDO SUPERCUT SCISSORS, MONOPOLAR, 3.5MM

    MDR report key: 687531 · Received March 14, 2006

    Report

    Report Number
    2430952-2006-00009
    Event Type
    Malfunction
    Date Received
    March 14, 2006
    Report Date
    March 14, 2006
    Manufacturer
    KOSCHER & WUERTZ GMBH
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCISSORS FROM PEDIATRIC LAPAROSCOPIC SET A BROKE WHILE BEING USED DURING A PROCEDURE AND THAT A MEDICAL INTERVENTION WAS REQUIRED. THE USER FACILITY WAS CONTACTED AND THE HOSPITAL ADDED THAT THE SCISSORS WERE DULL AND NOT CUTTING TISSUE. THE INSTRUMENT WILL NOT BE RETURNED FOR INVESTIGATION BUT AVAILABLE FOR ON-SITE INSPECTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARIT ENDO SUPERCUT SCISSORS, MONOPOLAR, 3.5MM JARIT ENDOSCOPIC INTRUMENTS KOG KOSCHER & WUERTZ GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *