PhotonGuide Wide / Flat (REF 104015)Recalls & reported problems
Stryker Corporation · Illuminator, Wide/Flat · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816728020080), received between Jul 26, 2023 and Dec 6, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device6
- Melted5
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2024Melted; Overheating of Device; Melted; Overheating of Device
IT WAS REPORTED THAT THE PRODUCT MELTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20868282 ↗MalfunctionFeb 27, 2024Melted; Overheating of Device; Melted; Overheating of Device
PER THE SURGEON, DURING A PROCEDURE THE PHOTONGUIDE MELTED WHILE BEING USED WITH A XENON LIGHT SOURCE. PER THE SURGEON THERE WAS NO INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18790426 ↗MalfunctionFeb 27, 2024Melted; Overheating of Device; Melted; Overheating of Device
PER THE SURGEON, DURING A PROCEDURE THE PHOTONGUIDE MELTED WHILE BEING USED WITH A XENON LIGHT SOURCE. PER THE SURGEON THERE WAS NO INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18790259 ↗MalfunctionFeb 27, 2024Melted; Overheating of Device; Melted; Overheating of Device
PER THE SURGEON, DURING A PROCEDURE THE PHOTONGUIDE MELTED WHILE BEING USED WITH A XENON LIGHT SOURCE. PER THE SURGEON THERE WAS NO INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18788846 ↗MalfunctionOct 23, 2023Fracture; Fracture
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17990687 ↗MalfunctionOct 23, 2023Melted; Overheating of Device; Melted; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED AND MELTED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17986905 ↗MalfunctionJul 26, 2023Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17397060 ↗
Other Light, Surgical, Carrier devices
- PhotonGuide Wide / FlatStryker Corporation · Light, Surgical, Carrier4 reports
- PhotonGuide AdaptStryker Corporation · Light, Surgical, Carrier4 reports
- PhotonGuide Narrow / FlatStryker Corporation · Light, Surgical, Carrier2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.