Precision IE 4K 0502-414-070Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327416435), received between Jun 15, 2022 and Aug 26, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (4 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 Image4
- Crack1
- Fogging1
- Insufficient Device Problem Information1
- Optical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463235 ↗MalfunctionDec 29, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE SCOPE WAS BLURRY ON THE FIRST USE.
Patient problems: Insufficient Information
MAUDE report 23911077 ↗MalfunctionJul 2, 2024Fogging; Poor Quality Image; Fogging; Poor Quality Image
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656470 ↗MalfunctionOct 13, 2022Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS POOR IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15601841 ↗MalfunctionJun 15, 2022Crack; Crack; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER ANESTHESIA, BUT NO INCISION WAS MADE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14699782 ↗
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
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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