Evis Exera Bronchofibervideoscope Olympus Bf Type XP160F, Its Accessories and Ancillary Equipment

• • Ongoing Z-0327-2024 FDA Class II ·initiated 25 Sep 2023

  Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

• • Ongoing Z-2491-2023 FDA Class II ·initiated 27 Jul 2023

  Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

• • Ongoing Z-1048-2022 FDA Class II ·initiated 8 Mar 2022

  Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

• • Terminated Z-2569-2021 FDA Class II ·initiated 16 Aug 2021

  The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

• • Terminated Z-3305-2018 FDA Class II ·initiated 8 Aug 2018

  The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

510(k) Number

K033225 ↗

FDA Product Code

EOQ

Device Class

Class II

Regulation

21 CFR Part 874.4680

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Hx-5/6-1 Endoscopic Clipping Device, Endoscopic Clips

  Class II

  FDA 510(k) K990687 Active Cleared 26 Mar 1999

• Olympus Ultrasonic Gastrovideoscope Gf Type UC140P-DO5 & Olympus Ultrasonic Gastrofiberscope Gf Type UC30P

  Class II

  FDA 510(k) K021886 Active Cleared 19 Jun 2002

• Olympus Ultrasonic Surgical System

  Unclassified

  FDA 510(k) K031305 Active Cleared 23 Sep 2003

• Olympus Neuro Endoscope

  Class II

  FDA 510(k) K971340 Active Cleared 29 Jul 1998

• Heat Scissors Generator Set and Heat Scissors Handpiece

  Class II

  FDA 510(k) K024138 Active Cleared 12 Mar 2003

• XTJF-160AF Duodenoscope

  Class II

  FDA 510(k) K024033 Active Cleared 20 Dec 2002

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