OES TRANSDUODENAL CHOLEDOCHOFIBERSCOPE OLYMPUS CHF TYPE BP30Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Sep 25, 2023Class IIIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0330-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Choledochoscope and accessories, flexible/rigid devices
- SpyScope DS M00546600Boston Scientific Corporation · Choledochoscope and accessories, flexible/rigid912 reports
- SpyScope™ DS II M00546610Boston Scientific Corporation · Choledochoscope and accessories, flexible/rigid2 deaths646 reports
- Forceps/Irrigation Plug (Isolated Type) MAJ-891Olympus Medical Systems Corp. · Choledochoscope and accessories, flexible/rigid1 recall1 death257 reports
- OES CHOLEDOCHOFIBERSCOPE OLYMPUS CHF TYPE CB30LOlympus Medical Systems Corp. · Choledochoscope and accessories, flexible/rigid1 recall9 reports
- SpyGlass™ Discover M00546780Boston Scientific Corporation · Choledochoscope and accessories, flexible/rigid1 death55 reports
- Tangent Digital catheter tng-4002-indTangent Endoscopy LLC · Choledochoscope And Accessories, Flexible/Rigid1 recall0 reports
- SpyGlass DS M0054665R0Boston Scientific Corporation · Choledochoscope and accessories, flexible/rigid19 reports
- DISPOSABLE GRASPING FORCEPS FG-55DOlympus Medical Systems Corp. · Choledochoscope and accessories, flexible/rigid17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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