D
Patient 1
THE LIGHT BULB ON THE PENTERO MICROSCOPE LIGHT SOURCE FAILED DURING USE. WHEN THE BULB FAILED GLASS MATERIAL LEFT THE CONFINE OF THE MICROSCOPE, MATERIAL WAS FOUND IN THE OR AND IN THE STERILE DRAPE AREA.
MAUDE MDR 1272491
- MDR report key
- 1272491
- Report number
- 2431026-2008-00005
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-11-04
- Date received
- 2008-12-19
- 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 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-12-19 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE SYSTEM AND MICROSCOPE WERE INSPECTED BY A SERVICE TECHNICIAN IN 2008. THE SERVICE TECHNICIAN DISCOVERED THAT GLASS WAS ON THE GROUND AND THE LIGHT BULB WAS BROKEN. THE HOSPITAL USED ANOTHER MICROSCOPE TO COMPLETE THE SURGERY.