Telescope, Rigid, Endoscopic
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
127 adverse event reports on file
- TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLEJan 12, 2024MalfunctionOlympus Winter & Ibe Gmbh9610773-2024-00159
- TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLEJan 12, 2024MalfunctionOlympus Winter & Ibe Gmbh9610773-2024-00160
- TELESCOPE "OES ELITE", 4 MM, 12°, HD, AUTOCLAVABLEDec 25, 2023MalfunctionOlympus Winter & Ibe Gmbh9610773-2023-03756
- TELESCOPE "OES ELITE", 4 MM, 12°, HD, AUTOCLAVABLEDec 25, 2023MalfunctionOlympus Winter & Ibe Gmbh9610773-2023-03760
- SECONDARY SET C62Oct 13, 2023MalfunctionBecton Dickinson3003152976-2023-00466
- VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLEMar 23, 2023MalfunctionOlympus Winter & Ibe Gmbh9610773-2023-00852
- M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEGSep 2, 2020MalfunctionGyrus Acmi, Inc1519132-2020-00063
- TELESCOPE "OES ELITE", 4 MM, 12, HD, AUTOCLAVABLEJul 17, 2020InjuryOlympus Winter & Ibe Gmbh9610773-2020-00158
- TELESCOPE "OES ELITE", 4 MM, 70, HD, AUTOCLAVABLEJun 23, 2020MalfunctionOlympus Winter & Ibe Gmbh9610773-2020-00142
- M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEGJun 19, 2020MalfunctionGyrus Acmi, Inc1519132-2020-00022
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
Olympus Winter & Ibe Gmbh
HAMBURG, DE
Teleflex Llc (nadc)
Olive Branch, MS, US
Mdtglobal, A.s.
Bratislava Bratislavsky, SK
Arvato Se
Hamburg, DE
Teleflex Medical Llc
Morrisville, NC, US
Ian Jamieson Pty Ltd
Fyshwick Australian Capital Territory, AU
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Richard Wolf Gmbh
KNITTLINGEN Baden-Wurttemberg, DE
510(k) clearances
5 clearances for this product code
- Olympus Winter & Ibe GmbHNov 24, 2015
K151191 · OES ELITE Telescopes, Protective Tube
- Endoservice Optical Instruments GmbHAug 21, 2012
K113062 · ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES
- Acmi CorporationSep 2, 2003
K031758 · ACMI M4 TELESCOPES
- Richard Wolf Medical Instruments Corp.Mar 5, 1999
K984607 · PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX
- V. Mueller O.V. Baxter Healthcare Corp.Aug 30, 1976
K760177 · TELESCOPE, RIGID ENDOSCOPE