Endoscope, Flexible
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
90 adverse event reports on file
- UNKNOWNJun 12, 2024MalfunctionAizu Olympus Co., Ltd.9610595-2024-11862
- UNKNOWNJun 7, 2024MalfunctionAizu Olympus Co., Ltd.9610595-2024-11518
- UNKNOWN OLYMPUS SCOPEJun 23, 2023MalfunctionAizu Olympus Co., Ltd.9610595-2023-09258
- SCOPEJan 11, 2023MalfunctionAizu Olympus Co., Ltd.9610595-2023-00608
- UNKNOWNNov 2, 2022MalfunctionAizu Olympus Co., Ltd.9610595-2022-03577
- UNKNOWNOct 6, 2022MalfunctionAizu Olympus Co., Ltd.9610595-2022-02652
- UNKNOWNSep 14, 2022MalfunctionAizu Olympus Co., Ltd.9610595-2022-01823
- PENTAXJun 30, 2022MalfunctionHoya Corporation Pentax Tokyo Office9610877-2022-00515
- PENTAXJun 30, 2022MalfunctionHoya Corporation Pentax Tokyo Office9610877-2022-00516
- PENTAXMay 3, 2022MalfunctionHoya Corporation Pentax Tokyo Office9610877-2022-00498
Event type breakdown
Recalls
22 recall events for this product code
- Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0889-2016 · View FDA record ↗ - Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0890-2016 · View FDA record ↗ - Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0891-2016 · View FDA record ↗ - Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0892-2016 · View FDA record ↗ - Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0893-2016 · View FDA record ↗ - Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0894-2016 · View FDA record ↗ - Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0895-2016 · View FDA record ↗ - Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0896-2016 · View FDA record ↗ - Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0897-2016 · View FDA record ↗ - Integrated Medical Systems IncTerminatedUnknown
Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Z-0898-2016 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Codman & Shurtleff, Inc.Mar 23, 1993
K920979 · CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340)
- Medical Laser, Inc.Jun 22, 1990
K900894 · MEDILASE SERIES 2100 ENDOSCOPE
- Codman & Shurtleff, Inc.Aug 25, 1987
K871978 · CODMAN FLEXIBLE ENDOSCOPE
- Cooper Lasersonics, Inc.Feb 10, 1987
K864960 · TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL.
- Van-Tec, Inc.Apr 23, 1986
K860771 · VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE