Precision IE 4K 0502-444-030Recalls & reported problems
Stryker Corporation · Class 2
All models of Precision IE 4K (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Precision IE 4K arthroscope is a rigid camera scope used to look inside joints during surgery. Most of the 72 reports describe the scope fogging up inside, producing poor or unclear images; one report mentions a crack, and there is 1 injury and no deaths. Reports naming this identifier jumped from 7 in the previous 12 months to 31 in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 91
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 07613327405958), received between Jul 29, 2019 and Sep 18, 2026 — classified as 1 injury, 90 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (50 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 Image50
- Fogging36
- Optical Problem21
- Moisture or Humidity Problem3
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions87
- Insufficient Information8
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831063 ↗MalfunctionSep 16, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794039 ↗MalfunctionSep 14, 2026Fogging; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765760 ↗MalfunctionSep 11, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744512 ↗MalfunctionSep 11, 2026Fogging
It was reported that the scope had foggy lens and the fogginess was not able to be wiped off when attempted to wipe.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735027 ↗MalfunctionSep 11, 2026Fogging
It was reported that the scope was foggy. The fogginess could not be resolved when attempted to be wiped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725368 ↗MalfunctionSep 9, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697265 ↗MalfunctionSep 9, 2026Poor Quality Image
It was reported that the scope was blurry.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681741 ↗MalfunctionSep 9, 2026Poor Quality Image
It was reported that there was blurry image.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681737 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576826 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575850 ↗MalfunctionSep 2, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575110 ↗MalfunctionSep 1, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50553575 ↗MalfunctionSep 1, 2026Fogging
It was reported that scope was foggy and dark.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50553478 ↗MalfunctionSep 1, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50552992 ↗MalfunctionSep 1, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551674 ↗MalfunctionSep 1, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534331 ↗MalfunctionSep 1, 2026Fogging; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534330 ↗MalfunctionSep 1, 2026Poor Quality Image
It was reported that the scope was blurry.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534326 ↗MalfunctionAug 28, 2026Fogging
It was reported that the scope was foggy on the inside when used for the first time upon taking the scope from the sterile packaging and attached to the camera head.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502868 ↗MalfunctionAug 26, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50462065 ↗MalfunctionAug 26, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50462053 ↗MalfunctionAug 26, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50462047 ↗MalfunctionAug 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311071 ↗MalfunctionAug 18, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310945 ↗
Other Arthroscope devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- 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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