SPY 0502538030Recalls & reported problems
Stryker Corporation · . · Class 2
All models of SPY (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327575231), received between Apr 11, 2023 and Sep 21, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Fogging” (11 reports).
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
- Fogging11
- No Display/Image2
- Optical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848339 ↗MalfunctionSep 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829436 ↗MalfunctionSep 2, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564925 ↗MalfunctionSep 1, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554101 ↗MalfunctionSep 1, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534432 ↗MalfunctionSep 1, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534335 ↗MalfunctionAug 31, 2026Fogging
It was reported that the scope was foggy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534265 ↗MalfunctionAug 31, 2026No Display/Image
It was reported that the scope initially had visibility and then couldn't see through at all in middle of case and the scope also had backlight issues.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530582 ↗MalfunctionAug 31, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50528773 ↗MalfunctionAug 17, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289304 ↗MalfunctionAug 11, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202874 ↗MalfunctionAug 11, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201870 ↗MalfunctionDec 14, 2023Fogging; Optical Problem; Fogging; Optical Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332169 ↗MalfunctionApr 11, 2023Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16718657 ↗
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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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