D
Patient 1
THE USER FACILITY REPORTED AN INCIDENT DESCRIBED AS A PT BURN. SUBSEQUENT ADD'L INFO DESCRIBED THE BURN AS A 3RD DEGREE BURN SURROUNDING THE INCISION FOR A GLOMUS TUMOR.
MAUDE MDR 891533
- MDR report key
- 891533
- Report number
- 2431026-2007-00011
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-07-12
- Date received
- 2007-08-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KENT JONES
- Address
- 5160 HACIENDA DR DUBLIN CA 94568 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OPMI PENTERO | SURGICAL MICROSCOPE | CARL ZEISS SURGICAL GMBH. | EPT | 000000 1290 983 | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-08-10 | 0 | 1. O |
Event Narratives#
N
Patient 1
DURING AT LEAST PART OF THE SURGERY, THE LIGHT INTENSITY WAS SET AT 100%. THE SYSTEM AND THE LIGHT SOURCE HAVE BEEN INSPECTED BY A TRAINED SERVICE TECHNICIAN AND FOUND TO WORK ACCORDING TO THE SPECIFICATIONS. THE LABELING PROVIDES A RECOMMENDATION TO USE THE LOWEST LIGHT SETTING NECESSARY FOR THE PROCEDURE, REDUCING THE EXPOSURE TO A MINIMUM. ADDITIONAL TRAINING HAS BEEN OFFERED.