Xues-41 Endoscopic Electrosurgical Unit

• 2 recalls, same reason

  • Terminated Z-0829-2012 FDA Unclassified (pre-2012) ·initiated 27 Dec 2011
  • Terminated Z-0828-2012 FDA Unclassified (pre-2012) ·initiated 27 Dec 2011

  Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements

• • Terminated Z-1277-2013 FDA Class II ·initiated 10 Nov 2009

  Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that

510(k) Number

K030194 ↗

FDA Product Code

KNS

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Disposable Bending Cannula Pr-233Q

  Class II

  FDA 510(k) K011149 Active Cleared 15 May 2001

• XBO1-824-18/19/20 Biopsy Forceps

  Class II

  FDA 510(k) K012074 Active Cleared 25 Sep 2001

• Disposable Aspiration Needle Na-200H

  Class II

  FDA 510(k) K023272 Active Cleared 23 Dec 2002

• Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model Xcf-Q140L/13D

  Class II

  FDA 510(k) K002749 Active Cleared 4 Dec 2000

• Olympus Um 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract

  Class II

  FDA 510(k) K001203 Active Cleared 26 May 2000

• Xenf-Dp Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment

  Class II

  FDA 510(k) K011869 Active Cleared 25 Jul 2001

See all devices from The Olympus Optical Co. →