SPY 0502538010Recalls & 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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 07613327575224), received between Dec 14, 2023 and Sep 30, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Fogging” (25 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
- Fogging25
- No Display/Image1
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953980 ↗MalfunctionSep 28, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926188 ↗MalfunctionSep 25, 2026Fogging
It was reported that the scope was producing a blurred and foggy image, even after cleaning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898516 ↗MalfunctionSep 23, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876277 ↗MalfunctionSep 23, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876266 ↗MalfunctionSep 22, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862665 ↗MalfunctionSep 22, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862664 ↗MalfunctionSep 22, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862566 ↗MalfunctionSep 21, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848338 ↗MalfunctionSep 21, 2026Fogging
It was reported that the scope was cloudy and the cloudiness did not go off when cleaned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842492 ↗MalfunctionSep 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831234 ↗MalfunctionSep 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831062 ↗MalfunctionSep 16, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796735 ↗MalfunctionSep 16, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794240 ↗MalfunctionSep 11, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744508 ↗MalfunctionSep 9, 2026Fogging
It was reported that the scope was foggy during case.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681817 ↗MalfunctionSep 9, 2026Fogging
It was reported that there was cloudy image.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681809 ↗MalfunctionSep 2, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575849 ↗MalfunctionSep 1, 2026Fogging
It was reported that there was foggy image.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554181 ↗MalfunctionSep 1, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534333 ↗MalfunctionAug 31, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532308 ↗MalfunctionAug 31, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530580 ↗MalfunctionAug 17, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289697 ↗MalfunctionAug 13, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50244862 ↗MalfunctionAug 12, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229352 ↗
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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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