The FDA today issued a notice warning of the removal of certain single-use guide sheath kits for endoscope instruments by Olympus.
This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type of recall, as it may cause serious injury or death.
Olympus warned customers to not use single-use guide sheath kits with model numbers models K-201, K-202, K-203 or K-204. In a Jan. 15 urgent medical device removal letter, the company told customers to quarantine any affected product. These devices are used with Olympus endoscopes to collect cells or tissue specimens in the organs responsible for breathing.
The company said it received complaints that the radiopaque tip of the guide sheath component fell off into the patient. Preliminary findings showed that the tip detaches from the guide sheath as a result of the application of excessisve force as instruments are inserted into the guide sheath and/or if there is damage to the distal end of the sheath.
Using affected product may cause serious adverse health consequences, including bleeding and death. Olympus received 26 reports of injuries. The company received zero reports of death related to the issue.
Affected Olympus devices listed below:
- Product Names: Single Use Guide Sheath Kits:
- K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush
- K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps
- K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush
- K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps
- Unique Device Identifier (UDI)/Model:
- 04953170245466/K-201
- 04953170245480/K-202
- 04953170245503/K-203
- 04953170245527/K-204
- Lot Numbers: All lots
