Events

Rappel de Device Recall Starion Instruments 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
    55043
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2239-2010
  • Date de mise en oeuvre de l'événement
    2010-03-09
  • Date de publication de l'événement
    2010-08-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89744
  • 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/cauterization and accessories - Product Code GEI
  • Cause
    The starion instruments thermal ligating shears (stls) 35c and the starion thermal ligating shears (stls) 23c may turn on and remain on without the finger button being depressed. the devices may also work intermittently, incorrectly indicating the device is 'on".
  • Action
    Starion distributed a "STLS Device Recall - Important Medical Device Information" letter dated March 9, 2010 to consignees. The letter identified the affected model and lot numbers. Consignees were asked to complete a inventory status form and fax to Starion. the letter included a shipping labe with a pre-assigned return authorization number. Starion will ship replacement after receipt of the inventory status form and returned product..

Device

Device Recall Starion Instruments Thermal Ligating Shears
  • Modèle / numéro de série
    STLS 23C: Model numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022  STLS 35C: Model 102-138D, Lot Numbers: 907004 and 907008
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany.
  • Description du dispositif
    The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting 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