Precision IE 4K 0502-444-070Recalls & 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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327405910), received between Sep 16, 2019 and Sep 3, 2026 — classified as 9 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
- Fogging4
- Optical Problem3
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50577003 ↗MalfunctionSep 2, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576827 ↗MalfunctionSep 1, 2026Poor Quality Image
It was reported that a blurry lens was noticed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534332 ↗MalfunctionAug 27, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50465560 ↗MalfunctionJan 17, 2024Fogging; Optical Problem; Fogging; Optical Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531182 ↗MalfunctionDec 21, 2023Fogging; Material Integrity Problem; Fogging; Material Integrity Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18374784 ↗MalfunctionApr 18, 2022Optical Problem; Poor Quality Image; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14138324 ↗MalfunctionSep 18, 2019Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED IMAGE WAS FOGGY DURING PROCEDURE. ADDITIONAL INFORMATION CONFIRMED A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9082973 ↗MalfunctionSep 16, 2019Poor Quality Image
IT WAS REPORTED THAT THERE WAS A FOGGY IMAGE DURING THE PROCEDURE. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9070710 ↗
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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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