Various Olympus Medical Systems Corp.'s Bronchofibervideoscope, Bronchofiberscope and Laryngoscope products (2018-09-26)

Starting date:
September 26, 2018
Posting date:
November 30, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68478

Affected products

A. EVIS EXERA Ultrasonic Bronchofibervideoscope
B. EVIS EXERA II Video System Bronchofibervideoscope
C. VISERA Video Rhino Laryngoscope
D. EVIS EXERA Video System  Bronchovideoscope
E. EVIS 240 Video System Bronchofibervideoscope
F. OES Bronchofiberscope
G. EVIS EXERA Video System Bronchofibervideoscope
H. EVIS EXERA II Ulrrasonic Bronchofibervideoscope
I. Airway Mobilescope Therapeutic

Reason

Olympus received a complaint outside of Canada claiming that patients were infected after a bronchoscopy procedure in which a BF-1T180 bronchoscope with a loosened instrument channel port was used. As a result of Olympus’s investigation, it was discovered that 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.

In an effort to maximize patient safety and mitigate any potential risk to patient health, Olympus is notifying users of this complaint and the need for careful inspection of the endoscope's instrument channel port prior to use in accordance with the instructions provided. Additionally, Olympus is providing updated Instruction For Uses (IFU).

Affected products

A. EVIS EXERA Ultrasonic Bronchofibervideoscope

Lot or serial number

All lots.

Model or catalog number

BF-UC160F-OL8

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN

B. EVIS EXERA II Video System Bronchofibervideoscope

Lot or serial number

All lots.

Model or catalog number

BF-1T180
BF-1TQ180
BF-P180
BF-Q180
BF-Q180-AC

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN

C. VISERA Video Rhino Laryngoscope

Lot or serial number

All lots.

Model or catalog number

ENF-VT2

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN

D. EVIS EXERA Video System  Bronchovideoscope

Lot or serial number

All lots.

Model or catalog number

BF-160
BF-1T160
BF-3C160
BF-P160
BF-XT160

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN

E. EVIS 240 Video System Bronchofibervideoscope

Lot or serial number

All lots.

Model or catalog number

BF-1T240
BF-240
BF-6C240
BF-P240

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN

F. OES Bronchofiberscope

Lot or serial number

All lots.

Model or catalog number

BF-1T40
BF-1T60
BF-3C40
BF-40
BF-MP60
BF-P40
BF-P60
BF-XP40
BF-XP60

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN

G. EVIS EXERA Video System Bronchofibervideoscope

Lot or serial number

All lots.

Model or catalog number

BF-MP160F
BF-XP160F

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN

H. EVIS EXERA II Ulrrasonic Bronchofibervideoscope

Lot or serial number

All lots.

Model or catalog number

BF-UC180F

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN

I. Airway Mobilescope Therapeutic

Lot or serial number

All lots.

Model or catalog number

MAF-TM

Companies
Manufacturer
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-shi, Tokyo
192-8507
JAPAN