Ellik Evacuator surgical device sterilization instructions differ between language versions
Olympus is recalling Ellik Evacuator Model 191-NRS due to discrepancies between sterilization instructions in Japanese-language product inserts and the manufacturer's English Instructions For Use. Sterilization instruction discrepancies may affect proper device preparation before use.
What this means for you
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 Class II medical device presents a risk-of-harm situation due to sterilization instruction discrepancies that could affect proper device preparation. While no illnesses or injuries have been reported, improper sterilization of surgical instruments poses a patient safety risk, meeting the criteria for High severity.
Plain-English summary
Olympus Corporation of the Americas is recalling the Ellik Evacuator Model 191-NRS, a cone with male tubing used in urological surgical procedures. The recall is issued due to discrepancies between sterilization instructions in the Japanese-language product package inserts and those in the manufacturer's official Instructions For Use. This device is designed to be compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Sterilization of medical devices prior to clinical use is essential for patient safety. The discrepancies between different versions of sterilization instructions may affect the proper preparation of the device prior to use. The recall applies to all lot numbers of Model 191-NRS with UDI-DI 00821925003545, which were distributed to Japan.
The recalled product
- Product
- Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- sterilization-instruction-discrepancy
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 191-NRS. UDI-DI: 00821925003545. All lot numbers
Distribution
Distribution scope not specified by the agency.
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