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