Precision IE 4K 0502-445-030Recalls & reported problems
Stryker Corporation · Class 2
All models of Precision IE 4K (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327405927), received between May 9, 2022 and Feb 11, 2026 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (7 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
- Optical Problem7
- Poor Quality Image3
- Material Integrity Problem1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Poor Quality Image
IT WAS REPORTED THAT SCOPE LENS IS DAMAGED AND AND HAS VERY LIMITED VISIBILITY. IMAGE WAS BLURRY AND HAD DARK SHADE OF TINT AND WOULDN¿T CLEAR UP. THEY SWAPPED SCOPE TO A BACKUP AND FINISHED CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24316492 ↗InjuryDec 2, 2024Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem
IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, 20-25MM OF THE SCOPE STUCK OUT OF THE CANNULA AND THEY COULD NOT REACH THE JOINT. ADDITIONAL INCISIONS WERE MADE IN ORDER TO REACH THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20821124 ↗MalfunctionSep 13, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17739283 ↗MalfunctionJul 5, 2023Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17262882 ↗MalfunctionNov 11, 2022Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15782443 ↗MalfunctionAug 25, 2022Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15296513 ↗MalfunctionAug 25, 2022Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15293993 ↗MalfunctionJul 21, 2022Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15073980 ↗MalfunctionJul 21, 2022Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15073973 ↗MalfunctionMay 9, 2022Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE DURING PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14337552 ↗
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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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