FDA Adverse Event
Summary report: N
SOFAMOR DANEK MAST QUADRANT ILLUMINATION SYSTEM
MDR report key: 2770205
·
Received September 21, 2012
Report
- Report Number
- 2770205
- Date Received
- September 21, 2012
- Date of Event
- September 18, 2012
- Report Date
- September 21, 2012
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA
- Product Code
- FST
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT WITH LUMBAR SPINAL STENOSIS WAS UNDERGOING LAMINECTOMY (L4-5) POSTERIOR SPINAL FUSION IN OPERATING ROOM. PATIENT WAS POSITIONED PRONE. SURGEON WAS USING THE QUADRANT ILLUMINATION SYSTEM DURING THE PROCEDURE. REPRESENTATIVE FROM ILLUMINATION SYSTEM MANUFACTURER PRESENT IN OR DURING PROCEDURE. THE ILLUMINATION SYSTEM WAS ATTACHED TO THE STANDARD OR LIGHT SOURCE. DURING THE PROCEDURE, THE DEVICE WAS FOUND TO BE VERY HOT AT THE CONNECTION FROM THE RETRACTOR CONNECTION TO THE LIGHT CORD. DEVICE WAS IMMEDIATELY TAKEN OUT OF SERVICE. PATIENT IMMEDIATELY ASSESSED AND NO INJURY IDENTIFIED. HOWEVER, AT THE TIME OF CLOSURE, AN AREA OF REDNESS WITH ONE SMALL BLISTER WAS NOTED ON THE PATIENT'S RIGHT UPPER BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFAMOR DANEK MAST QUADRANT ILLUMINATION SYSTEM | LIGHT, SURGICAL, FIBEROPTIC | FST | MEDTRONIC SOFAMOR DANEK USA | 9450059 | 0203995W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |