Device product
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Z-1090-2026
Product summary
- Event
- Event 98197
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-1090-2026
Official wording
Reason: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Code information: UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.