Stryker · Model StrykeFlow II
• Disposable pump and hand piece • Tubing offered with disposable or reusable tip attachments • Self priming system • Spike and go easy installation and disposal
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
No documents available for this device yet.
Synced live from the FDA openFDA API.
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
Devices for which sterility may be compromised as evidenced by a crack in the package.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
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