1788 1788210080Recalls & reported problems
Stryker Corporation · 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 07613327580020), received between Apr 10, 2024 and Apr 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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
- Electrical /Electronic Property Problem1
- Fogging1
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.
MalfunctionApr 10, 2024Electrical /Electronic Property Problem; Fogging; Electrical /Electronic Property Problem; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19084507 ↗
Other Microscope, surgical devices
- M530 Optics Carrier 000000000010448704Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL4 reports
- PROvido 000000000010448950Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL3 reports
- M530 OHX 000000000010448737Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL3 reports
- PROvido 000000000010448976Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- M525 F20 000000000010448284Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL2 reports
- IMAGE1 PILOT TC014Karl Storz GmbH & Co. KG · MICROSCOPE, SURGICAL2 reports
- M530 Optics Carrier 000000000010448700Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL1 report
- ARveo 000000000010448999Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL1 report
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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