Zoom microscope body OCS5-ZBRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 13, 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 04953170331763), received between Jan 5, 2024 and Jan 5, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component1
- Detachment of Device or Device Component1
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.
MalfunctionJan 5, 2024Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component
CORRECTION TO B5 OF THE INITIAL REPORT. ON 07MAR2022 THE USER FACILITY NOTED NON-REPORTABLE MALFUNCTIONS OF A BROKEN HEAD, DAMAGED LENSES AND OPTICS. IT IS UNKNOWN IF THE ISSUE OCCURRED ON THAT DATE OR EARLIER. AN INCORRECT MODEL NUMBER WAS COMMUNICATED TO OLYMPUS AND THE USER FACILITY COULD NOT COMMUNICATE THE CORRECT MODEL NUMBER. ON 12FEB2024 THE SUBJECT DEVICE (A ZOOM MICROSCOPE BODY) WITH THE SAME SERIAL NUMBER WAS EVALUATED WHERE A REPORTABLE MALFUNCTION OF BREAKAGE OF THE COLPOSCOPE WAS NOTED WHERE THE ZOOM MICROSCOPE BODY WAS DISCONNECTED FROM THE BALANCE ARM. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION NOTED DURING THE DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18451623 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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