PHOTONGUIDE, WIDE/FLAT
Received Feb 27, 2024 · Event occurred Dec 29, 2023
Report 3015967359-2024-00427 · MDR key 18788846
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
104015
Lot number
23144W
Product problems
- Melted
- Overheating of Device
- Melted
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
UPDATE: H3, H6 DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE EVALUATION.
Description of Event or Problem
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.