BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Information about the Instructions for Use for the EG-3870UTK Ultrasound Video Gastroscope, Pentax

Product group Optics / Precision engineering - endoscopes
Reference 04520/12

Pentax has issued a Field Safety Notice concerning a revision of the instructions for use to clarify the method for advancing an accessory in the Ultrasound Video Gastroscope EG-3870UTK. If the user fails to properly position the elevator, the accessory can disengage from the elevator and there is the possibility that the accessory does not appear in the endoscopic view and sonographic view.

Information about the Instructions for Use for the EG-3870UTK Ultrasound Video Gastroscope, Pentax , Download_VeroeffentlichtAm_EN PDF, 94KB, File does not meet accessibility standards