Events

Retiro De Equipo (Recall) de Device Recall A20975A: Working insert, with ramp, one way; A20976A: Bridge, one way; A20977A; Bridge, two way

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 Olympus Corporation of the Americas.

¿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
    79017
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0696-2018
  • Fecha de inicio del evento
    2017-08-18
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161176
  • 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
    Endoscope, ac-powered and accessories - Product Code GCP
  • Causa
    Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. cracking, chipping, missing pieces, and delamination of the adhesive have also been reported. in one case, a fragment of the adhesive was detected inside a patient's urethra during a procedure and was retrieved without injury to the patient. the manufacturer, olympus winter & lbe gmbh ("owi") has determined that adhesive can be dislodged during the intended use of the cystoscopy bridge or working insert, e.G., when inserting an instrument through the working channel. as a result, a fragment of the adhesive may fall inside the patient's bladder, urethra or uterus and would need to be retrieved, extending the length of the procedure or requiring additional surgical treatment. the adhesive is used to seal gaps inside the working channel of the cystoscopy bridges and working inserts. in 2013, the adhesive used until then was discontinued and had to be replaced. current investigations revealed that the durability of the new adhesive is insufficient.
  • Acción
    On August 18, 2017 an URGENT Medical Device Removal and Corrective Action letter was sent to customers regarding the "Cystoscopy Bridges and Working Inserts" instructing customers to review their inventory, quarantine affected product and call customer service at 800-848-9024 to arrange return and replacement.

Device

Device Recall A20975A: Working insert, with ramp, one way; A20976A: Bridge, one way; A20977A; B...
  • Modelo / Serial
    Model Numbers and Associated Lot Numbers: A20975A -- 13-ZW to 172W A20976A -- 146W to 172W A20977A -- 146W to 174W
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) || Product Usage: || A20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.
  • Manufacturer
    Olympus Corporation of the Americas

Manufacturer

Olympus Corporation of the Americas
  • Dirección del fabricante
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    USFDA