Olympus Corporation of the Americas Recalls

Hazard: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

Hazard: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

Hazard: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

Hazard: Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

Hazard: Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.

Hazard: Preset treatment parameters are not consistently being used in accordance with the IFU.

Hazard: Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Hazard: Potential for distal tip tearing of the Mechanical Lithotriptor V.

Hazard: Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.

Hazard: Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.

Hazard: High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).

Hazard: To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.

Hazard: Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.

Hazard: Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.

Hazard: There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).

Hazard: Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention

Hazard: During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.

Hazard: Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch

Hazard: It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.