SOLTIVE SuperPulsed Laser Fibers Recalled for Potential Fiber Breakage During Surgery
Olympus is recalling 82,200 units of SOLTIVE SuperPulsed Laser Fibers due to instruction inconsistencies that could cause fiber breakage during use, potentially resulting in burns or foreign material in the patient.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a risk-of-harm product with instruction defects that could cause fiber breakage during surgical use, potentially resulting in burns and foreign body complications. No illnesses or injuries have been reported, limiting severity to High per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 82,200 units of SOLTIVE SuperPulsed Laser Fibers due to inconsistencies in the Instructions for Use regarding fiber tip cleaning, cleaving, and stripping procedures. All affected lots are included in this recall.
If used according to the current instructions, the fiber could break during surgical use, which may cause burns, procedure delays, prolonged surgery, and foreign material remaining in the patient.
The recalled fiber models include TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, and TFL-FBX200BS. The product has been distributed worldwide, including throughout the US and in Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America.
Patients and healthcare providers who have received these fibers should consult Olympus Corporation for corrected instructions before further use.
The recalled product
- Product
- SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
- Manufacturer
- Olympus Corporation of the Americas
Distribution
Distributed nationwide across the United States.
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