Clarus Digital ChannelScope Endoscope, 13.0cm 2233-513Recalls & reported problems
Clarus Medical, LLC · Clarus Digital ChannelScope Endoscope, 13.0cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810004820012), received between Dec 28, 2025 and Jan 3, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2026Fluid/Blood Leak
DURING THE CASE 12/3/25 THEY HAD AN ISSUE WITH A MODEL 2233-513 DIGITAL CHANNELSCOPE (LOT 520504) LEAKING IRRIGATION FLUID OUT OF THE IMAGE CONNECTOR AND INTO THE DIGITAL CONTROL MODULE. NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23953012 ↗MalfunctionDec 28, 2025Leak/Splash; Leak/Splash
DURING A CASE ON 10/24 USING A MODEL (B)(6) DIGITAL CHANNELSCOPE LOT # 520261, THE MONITOR WENT BLACK. THEY UNPLUGGED THE DEVICE AND NOTICED IRRIGATION FLUID COMING OUT OF THE CONNECTOR. THEY ATTEMPTED A NEW MODEL (B)(6) DIGITAL CHANNELSCOPE AND IT DID NOT DISPLAY AN IMAGE. THEY DID NOT HAVE A BACKUP (B)(6) DIGITAL CONTROL MODULE ON HAND, SO THEY SWITCHED TO A DIFFERENT SYSTEM TO FINISH THE CASE. NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903608 ↗
Other Endoscope, Neurological devices
- AESCULAP FF399RAesculap AG · ENDOSCOPE, NEUROLOGICAL2 recalls0 reports
- VS3-IR 161-0001Visionsense Ltd. · Endoscope, Neurological1 recall4 reports
- VS3-IR 174-0012Visionsense Ltd. · Endoscope, Neurological1 recall1 report
- Aurora® Surgiscope® ASX9/130Integra Lifesciences Corporation · Endoscope, neurological1 recall0 reports
- IMAGE1 S CONNECT TC201USKarl Storz GmbH & Co. KG · Endoscope, neurological34 reports
- Artemis AP28-APenumbra, Inc. · Endoscope, Neurological4 deaths31 reports
- NA 1688410105Stryker Corporation · Endoscope, neurological24 reports
- Apollo System AP9Penumbra, Inc. · ENDOSCOPE, NEUROLOGICAL10 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page