Events

Rappel de Leica M520 Surgical Microscope Systems

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Leica Microsystems, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    35385
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1162-06
  • Date de mise en oeuvre de l'événement
    2005-04-12
  • Date de publication de l'événement
    2006-06-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-05-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45967
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Surgical Microscope - Product Code EPT
  • Cause
    Patient burns-the use of the surgical microscope at high light intensity and short working distances can result in patient burns.
  • Action
    Leica Microsystems faxed a memo entitled 'M520 Heat Issues' to all IMRs on 11/15/05, informing them that the potential to burn exposed patient skin at the closer working distances with the high intensity of light exists with the M520 optics carrier and/or new optichrome light source. The IMRs were sent retrofit packets which consisted of a current User Manual with 'Caution: The light source in this unit may be too bright at shorter focal lengths for surgeon and patient. Please start with light low and turn up till the surgeon has an excellent optical image.'; a sticker reading 'Warning: Maximum Light at Short Distance Can Injure Patient See User Manual', to be placed on the stand near the light intensity controller; a laminated card entitled 'Setting the Illumination Intensity' to be hung on the stand with the enclosed wire tie for in-service training; and a training verification form. The IMRs were instructed to visit each of the end user locations on the enclosed list, installing the stickers, providing the new User Manual and providing the staff that uses the microscope another in-service, stressing the proper use of the illumination system. Upon completion of the in-service, the IMRs will complete the training verification form and have a staff member from the OR sign the form verifying that the warning labels were applied and that the staff was trained, and that the user manual was received. The IMRs will then return the verification form to Leica Microsystems.

Device

Leica M520 Surgical Microscope Systems
  • Modèle / numéro de série
    All units shipped prior to December 1, 2005
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated field continuously adjustable and high power 300W xenon lamp (both main and back-up illimuniation) through fiber optic cable; Leica Microsystems (Schweiz) AG, Business Unit SOM, Max Schmidheiny-Strasse 201, CH-9435 Heerbrugg, Switzerland; Leica Microsystems Inc., 90 Boroline Road, Allendale, NJ 07401; Leica Microsystems Inc., 2345 Waukegan Road, Bannockburn, IL 60015-9792 || The M520 microscope was sold with the following floor stands to form Leica Surgical Microscope Systems: || a) MS-1 floor stand with manual balancing for the microscope carrier in three axes and three electromagnetic and mechanical brakes; || b) MS-2 floor stand with 3 step balancing for the optical head, autobalance for the floor stand and six electromagnetic brakes; || c) MS-3 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: 1456 mm || d) ) OHS1 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, || e) OH3 floor stand with fully-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: Max. 1520 mm || f) F40 floor stand with continuously adjustable balancing system and four electromagnetic permanent magnetic brakes, Maximum reach 1496 mm
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Adresse du fabricant
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA