D
Patient 1
THE USER FACILITY REPORTED AN INCIDENT DESCRIBED AS A PT BURN ("LEVEL 2"). THE PT EXHIBITED A CIRCULAR BURN SURROUNDING THE SURGICAL AREA WHERE AN INCISION HAD BEEN MADE TO CONDUCT A SKIN GRAFT.
MAUDE MDR 1054098
- MDR report key
- 1054098
- Report number
- 2431026-2008-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-04-25
- Date received
- 2008-06-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KENT JONES
- Address
- 22 CARL ZEISS STRASSE OBERKOCHEN D-734 GM
- 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 | 1290-983 | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-06-02 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE MICROSCOPE WAS INSPECTED BY A SERVICE TECH ON APRIL 29, 2008 AND FOUND TO BE IN PROPER WORKING ORDER. UPON MEETING THE MEMBERS OF THE HOSPITAL, IT WAS DETERMINED THAT THE USER OF THE MICROSCOPE HAD NOT ATTENDED THE IN-SERVICE WHEN THE MICROSCOPE HAD BEEN INSTALLED AND THAT THE USER WAS NOT FAMILIAR WITH THE XENON ILLUMINATION. AN ADD'L IN-SERVICE WAS OFFERED TO THE CUSTOMER.