M844 F40 / M822 F40 000000000010448142Recalls & reported problems
Leica Microsystems (Schweiz) AG · F40 stand for M822 - for Leica surgical operating microscope systems: M822 F40 · 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 07630003526233), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Electrical Shock” (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
- Unintended Electrical Shock1
Patient problems
- Electric Shock1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2025Unintended Electrical Shock; Unintended Electrical Shock
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM GREECE STATING THAT A NURSE SUFFERED AN ELECTRIC SHOCK WHILE TRANSPORTING AN M822 F40 FROM THE STORAGE ROOM TO THE OPERATING ROOM. NO INJURIES OCCURRED. SHE DESCRIBED HER ARM AS FEELING NUMB FOR A FEW SECONDS. NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Electric Shock
MAUDE report 22541735 ↗
Other MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY devices
- AESCULAP PV010Aesculap AG · MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY3 recalls8 reports
- OPMI® LUMERA® 300 6137Carl Zeiss Suzhou Co., Ltd. · Microscope, Surgical, General & Plastic Surgery1 recall1 report
- M220 F12 000000000010448367Leica Microsystems (Schweiz) AG · MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- KINEVO® 900 6640Carl Zeiss Meditec AG · Microscope, Surgical, General & Plastic Surgery1 death1 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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