Resectoscope
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
940 adverse event reports on file
- PANOVIEWJul 20, 2026MalfunctionRichard Wolf Gmbh9611102-2026-00046
- RICHARD WOLF MEDICAL INSTRUMENTS 26 FR OBTURATORJul 17, 2026OtherMW6000009
- RICHARD WOLF 26 FR CATHETER SHEATHJul 16, 2026InjuryRichard Wolf Medical Instruments CorporationMW5190740
- INNER SHEATH FOR 27050 SCJul 7, 2026InjuryKarl Storz Se & Co. Kg9610617-2026-01565
- INNER SHEATH FOR 27050 SCJul 7, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01565
- PIRANHAJun 12, 2026InjuryRichard Wolf Gmbh9611102-2026-00029
- SHARKMay 29, 2026MalfunctionRichard Wolf Gmbh9611102-2026-00024
- RESECTOSCOPEMay 21, 2026MalfunctionOlympus Winter & Ibe Gmbh25240149
- LASER GUIDE PROBE, 1.5 MMMay 21, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01160
- OLYMPUS INNER / RESECTION SHEATHApr 27, 2026InjuryOlympus Medical Products CzechMW5187283
Event type breakdown
Recalls
33 recall events for this product code
- Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1438-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1439-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1440-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1441-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1442-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1443-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1444-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1445-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1446-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedFeb 20, 2026
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Z-1447-2026 · View FDA record ↗
Registered firms
98 firms currently registered for this product code
Steris Ast Cz S.r.o.
VELKA BITES Vysocina, CZ
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Sterigenics U.s. Llc
Hayward, CA, US
Arvato Se
Hamburg, DE
Richard Wolf Medical Instruments Corp.
VERNON HILLS, IL, US
Flexbar Machine Corp.
ISLANDIA, NY, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Sterigenics Us Llc
Fort Worth, TX, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Olympus Medical Products Czech
Prerov II Predmosti, CZ
Sklar Corporation - Warehouse
Salisbury, MD, US
Gyrus Medical Ltd.
CARDIFF Wales, GB
Rg Medical Usa
Mount Juliet, TN, US
All Quality & Services, Inc.
Fremont, CA, US
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Sterigenics U.s., Llc
Queensbury, NY, US
Olympus Winter & Ibe Gmbh
HAMBURG, DE
510(k) clearances
24 clearances for this product code
- Karl Storz SE & CO. KGMay 7, 2024
K232486 · KARL STORZ Monopolar Resectoscopes with HF Cable
- Karl Storz Endoscopy America, Inc.Mar 17, 2023
K221893 · KARL STORZ Bipolar Resectoscopes with HF Cable
- Corinth Medtech, Inc.Feb 24, 2023
K230205 · Veloxion System
- Corinth Medtech, Inc.Jun 13, 2019
K191341 · Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- Corinth Medtech, Inc.Mar 15, 2019
K190099 · Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch
- Corinth Medtech, Inc.Mar 24, 2017
K162979 · Veloxion System
- National Advanced Endoscopy Devices, Inc.Dec 30, 2010
K102663 · AED RESECTOSCOPE
- Richard Wolf Medical Instruments Corp.Mar 22, 2007
K062720 · S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES