Events

Rappel de Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears

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 Starion Instruments.

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
    55750
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1972-2010
  • Date de mise en oeuvre de l'événement
    2008-06-26
  • Date de publication de l'événement
    2010-07-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91719
  • 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
    electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.
  • Action
    The firm submitted an MDR but determined that there was no risk to health. E-mails were sent on June 26, 2008, to consignees, describing the product, the problem, and action to be taken by consignees. The consignees were ask to provide a list of all unused ThermaSeal devices and their locations, to return the products to Starion from the lots noted and to provide a copy of the attached letter to their sales force and customers if they choose. If you have any questions, please call (408) 522-5200 ext. 326 or (408) 350-9934.

Device

Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears
  • Modèle / numéro de série
    Model Number N-10700, lot numbers 80419, 806009, 804037, 804035, 804036, 804019A.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA || Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery.
  • Manufacturer
    Starion Instruments

Manufacturer

Starion Instruments
  • Adresse du fabricant
    Starion Instruments, 775 Palomar Ave, Sunnyvale CA 94085-2915
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    USFDA