eyeMAX(TM) Single-use Video Pancreaticobiliary Scope CDS22007Recalls & reported problems
Micro-Tech (Nanjing) Co., Ltd. · Minimum Required Working Channel :3.7mm,Minimum Working Channel Width:1.2mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06932503563697), received between Aug 28, 2025 and Aug 28, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Optical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2025Defective Device; Optical Problem; Defective Device; Optical Problem
IT WAS REPORTED THAT "WHILE DOING AN ERCP(ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY), THE EYEMAX EQUIPMENT MALFUNCTIONED TWICE, THE INTEGRATED LAMP STOPPED WORKING, WE WERE UNABLE TO USE THIS EQUIPMENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910606 ↗
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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.
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