Events

Rappel de Device Recall Specialty Care

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 Instrumed International, 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
    68725
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2726-2014
  • Date de mise en oeuvre de l'événement
    2014-05-30
  • Date de publication de l'événement
    2014-09-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128740
  • 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
    Additional caution statements have been added to the instructions for use for monopolar electrodes. 1) to avoid tissue carbonation, the operation voltage of the hf generator must not exceed 650 peak voltage (vp) for all monopolar electrodes. and 2) for all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.
  • Action
    Instrumed sent an URGENT: MEDICAL DEVICE CORRECTION letters dated May 30, 2014 to all consignees. The letters advised the consignees of the new warning statements on the product Instructions For Use and an instruction to complete and return the attached Response Request Form to Instrumed International. Consignees were further instructed to extend the recall to the retail level. For questions contact Instrumed Quality Manager at 847-908-6119.

Device

Device Recall Specialty Care
  • Modèle / numéro de série
    1) Instrumed Item No.: 250-08930; Specialty Care Catalog Code: 30-92221; Lot Number: 040413
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • Description du dispositif
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. || The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
  • Manufacturer
    Instrumed International, Inc.

Manufacturer

Instrumed International, Inc.
  • Adresse du fabricant
    Instrumed International, Inc., 626 Cooper Ct, Schaumburg IL 60173-4537
  • Société-mère du fabricant (2017)
    Avalign Technologies Inc.
  • Source
    USFDA