Precision IE 4K 0502-404-070Recalls & 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327416473), received between Sep 11, 2019 and Nov 11, 2021 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Optical Problem4
- Optical Distortion2
- Poor Quality Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Unspecified Tissue Injury3
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2021Adverse Event Without Identified Device or Use Problem; Optical Problem; Optical Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 12801068 ↗InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Optical Problem; Optical Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 12801026 ↗InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Optical Problem; Optical Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO OPEN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12800966 ↗InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Optical Problem; Optical Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 12800902 ↗MalfunctionSep 11, 2019Poor Quality Image; Optical Distortion; Optical Distortion
IT WAS REPORTED THERE WAS FOGGING DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8992876 ↗MalfunctionSep 11, 2019Poor Quality Image; Optical Distortion; Optical Distortion
IT WAS REPORTED THE IMAGE WAS FOGGY DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8992874 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page