KnifeLight 3300-001-000Recalls & reported problems
Stryker GmbH · KNIFE LIGHT 10,PK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34546540060113), received between Jun 6, 2018 and Oct 11, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED: "FLUORESCENT SUBSTANCES CAME OUT OF THE PRODUCT. DURING THE CARPAL TUNNEL SYNDROME OP, THE FLUORESCENT SUBSTANCES CAME OUT OF THE PRODUCT. THE PATIENT'S SKIN WAS STAINED WITH THE FLUORESCENT SUBSTANCES. THE SURGEON WIPED OUT THE SUBSTANCES AND REPLACE THE DEVICE WITH A NEW ONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES IS REPORTED. A 3 MINUTE SURGICAL DELAY OCCURRED TO REPLACE THE DEVICE AND WIPE OFF THE SUBSTANCES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15584308 ↗MalfunctionJun 6, 2018Break
PRIMARY CARPAL TUNNEL RELEASE PROCEDURE, RIGHT WRIST. AS REPORTED BY FACILITY'S CLINICAL MANAGER: "[SURGEON] WAS USING A KNIFE LIGHT TODAY AND THE TIP BROKE OFF IN THE PATIENT. HE HAS BEEN USING THEM FOR A WHILE AND FEELS LIKE HE DID NOT DO ANYTHING DIFFERENT, WITH THIS PATIENT. LUCKILY HE WAS ABLE TO RETRIEVE THE BROKEN PIECE WITHOUT DIFFICULTY. HE FEELS THIS IS VERY CONCERNING..." SURGICAL DELAY OF 30 SECONDS WAS REPORT. PATIENT WAS VISUALLY INSPECTED AND DEVICE WAS RE-ASSEMBLED AT THE BACK TABLE TO ENSURE THAT ALL PIECES WERE REMOVED FROM THE PATIENT. CLINICAL MANAGER INDICATED THAT THE OPERATIVE REPORT IS AVAILABLE, IF NEEDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7575483 ↗
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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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