MalfunctionFSR
QUANTUM POOL
Received Aug 9, 2023
Report MW5120814 · MDR key 17488091
Device
Generic name
Light, Headband, Surgical
Manufacturer
Integra Lifesciences CorporationModel number
STRYKER MODEL: QUANTUM POOLProduct problems
- Optical Problem
- Optical Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
(B)(6)(CC) CALLED TO REPORT THAT ANYTIME THEY HAVE THE HEADLAMPS ON AND LOOKING DOWN AT THE PATIENT OR LOOKING TOWARDS THE SCREEN THE HEADLIGHTS WOULD INTERFERE WITH THE CAMERA CAUSING TRACKING TO STOP. REFERENCE NUMBER: (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).