Precision IE 4K 0502-404-030Recalls & 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 surgical camera scope used to look inside joints. The 54 reports mostly describe image problems: blurry or foggy views that moisture will not wipe off, cracks, and other optical faults that sometimes stop the scope from being used mid-procedure. Four reports mention an injury; no deaths are described. There are no recalls naming this device. Reports rose sharply, from 1 in the previous 12 months to 17 in the most recent.
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
- 75
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 07613327416497), received between Jul 29, 2019 and Sep 30, 2026 — classified as 4 injuries, 71 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (41 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 Image41
- Fogging26
- Optical Problem16
- Crack7
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information1
- Moisture or Humidity Problem1
- Optical Distortion1
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- No Known Impact Or Consequence To Patient8
- Insufficient Information6
- Unspecified Tissue Injury2
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fogging; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954459 ↗MalfunctionSep 29, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940509 ↗MalfunctionSep 24, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886490 ↗MalfunctionSep 23, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876306 ↗MalfunctionSep 23, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876274 ↗MalfunctionSep 21, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848341 ↗MalfunctionSep 16, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794456 ↗MalfunctionSep 16, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794452 ↗MalfunctionSep 16, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794238 ↗MalfunctionSep 14, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765826 ↗MalfunctionSep 10, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725013 ↗MalfunctionSep 10, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725011 ↗MalfunctionSep 10, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724446 ↗MalfunctionSep 9, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50703159 ↗MalfunctionSep 9, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702914 ↗MalfunctionSep 9, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697725 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575574 ↗MalfunctionSep 1, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554568 ↗MalfunctionSep 1, 2026Poor Quality Image
It was reported that the scope was blurry.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554355 ↗MalfunctionSep 1, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50554184 ↗MalfunctionSep 1, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50553479 ↗MalfunctionAug 31, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534267 ↗MalfunctionAug 31, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534266 ↗MalfunctionAug 31, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532760 ↗MalfunctionAug 27, 2026Fogging
It was reported that the scope had foggy image. Original scope cannot be used for completing the procedure and the moisture in the scope cannot be wiped off.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487988 ↗
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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