Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-11-03 | Z-0639-2021 | Class II | Terminated | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedureDistribution: US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI. | 12,800 units | code info di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
Similar devices
- SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO OBP CORPORATION
- 3-Piece Valve Kit Micro-tech Usa
- 3-Piece Valve Kit Micro-tech Usa
- 3-Piece Valve Kit Micro-tech Usa
- 3-Piece Valve Kit Micro-tech Usa
- 3-Piece Valve Kit Micro-tech Usa
- 4-Piece Valve Kit Micro-tech Usa
- 4-Piece Valve Kit Micro-tech Usa
- 4-Piece Valve Kit Micro-tech Usa
- 4-Piece Valve Kit Micro-tech Usa
- 4-Piece Valve Kit Micro-tech Usa
- 4-Piece Valve Kit Micro-tech Usa
Select up to two to place side-by-side with this device.