Events

Rappel de Device Recall Direct Drive Grasper

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 Applied Medical Resources Corp.

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
    59367
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2987-2011
  • Date de mise en oeuvre de l'événement
    2011-06-17
  • Date de publication de l'événement
    2011-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102417
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Cause
    The recall was initiated because applied medical has confirmed specific lot numbers of the direct drive¿ grasper (model numbers c4130 and c4140) due to a potential weakness in the locking trigger, which could result in the trigger fracturing and the jaw locking in the closed position.
  • Action
    Applied Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 22, to all affected consignees. The letter described the product, problem and actions to be taken. Consignees were instructed to check their inventory for the recalled products and returned immediately as per the instructions. The letter instructs consignees to complete the attached Voluntary Recall Notification Confirmation Form and fax it to Regulatory Affairs at 949-713-8832 or email it to recall60342148@appliedmedical.com. For questions pertaining to product return contact Chris Jacobson, Sales Operations Administrator, at (949) 713-8652 or by email at cjacobson@appliedmedical.com. For regulatory questions contact Susan Fehrenbacher at (949) 713-8041 or by email at sfehrenbacker@appliedmedical.com.

Device

Device Recall Direct Drive Grasper
  • Modèle / numéro de série
    C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX:  1109789, 1110338, 1120502, 1121622, 1122986, 1125449, 1126857, 1128330, 1128927, 1129474, 1130990, 1131764, 1132586, 1136813, 1137334, 1139969, 1141463, 1142396, 1143131.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.
  • Description du dispositif
    Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE || GRASPER 10/BX || Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Adresse du fabricant
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Société-mère du fabricant (2017)
    Applied Medical Corporation
  • Source
    USFDA