Events

Retiro De Equipo (Recall) de Device Recall Direct Drive Grasper

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Applied Medical Resources Corp.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    59367
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2986-2011
  • Fecha de inicio del evento
    2011-06-17
  • Fecha de publicación del evento
    2011-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102416
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX: 1109421, 1109787, 1110340, 1119363, 1120205, 1120207, 1121053, 1121057, 1121624, 1121756, 1122974, 1123411, 1123710, 1123872, 1124355, 1124556, 1124717, 1125445, 1125447, 1125710, 1125887, 1126120, 1127581, 1127583, 1128329, 1128334, 1128336, 1128434, 1129471, 1129473, 1130479, 1131482, 1131483, 1131484, 1131485, 1131486, 1132587, 1133099, 1134795, 1134796, 1134799, 1135529, 1135553, 1136810, 1136814, 1137509, 1137511, 1138374, 1138557, 1139245, 1139247, 1139968, 1141460, 1141461, 1141462, 1141857, 1141859, 1142395, 1142398, 1143129, 1143130, 1143133, 1143609, 1144837, 1144838, 1144840, 1144841.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    Direct Drive Grasper, Model numbers C4130, 5MM X 35CM 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
  • Dirección del fabricante
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Empresa matriz del fabricante (2017)
    Applied Medical Corporation
  • Source
    USFDA