Precision IE 4K 0502-445-070Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327405941), received between May 25, 2023 and Sep 1, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (5 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
- Poor Quality Image5
- Optical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554354 ↗MalfunctionAug 28, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502870 ↗MalfunctionJan 7, 2026Poor Quality Image
IT WAS REPORTED THAT THE SCOPE LOOKED SCUFFED AND BLURRY AND PROCEDURE COMPLETED USING REPLACEMENT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995973 ↗MalfunctionAug 6, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING HIP ARTHROSCOPY, THE IMAGE WAS BLURRED. IMPOSSIBLE TO CONTINUE WITH THE LATTER. THE DEVICE WAS CHANGED AND THE OPERATION WAS COMPLETED. SOME TIME WAS LOST IN THE SURGERY TO FIND AN ALTERNATIVE SOLUTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22732528 ↗InjuryApr 23, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT A HIP ARTHROSCOPY WAS SCHEDULED FOR THAT DAY. DURING THE OPERATION, THE NEW 70° OPTIC BECAME BLURRED AND THEREFORE UNUSABLE, SO THE SURGEON DECIDED TO TRY AND CONTINUE WITH A 30° OPTIC, WHICH WAS NOT AT ALL SUITABLE FOR THE OPERATION, SO THE PATIENT'S HIP HAD TO BE OPENED TO CONTINUE AND FINALIZE THE OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890931 ↗MalfunctionMay 25, 2023Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17007868 ↗
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- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
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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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