D
Patient 1
USER FACILITY REPORTS THAT THE OPMI 9 FC MICROSCOPE DETACHED FROM THE ARTICULATED ARM AND FELL ONTO THE PHYSICIAN'S ARM AND ONTO PT. NO INJURY WAS REPORTED.
MAUDE MDR 906456
- MDR report key
- 906456
- Report number
- 2431026-2007-00012
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-07-08
- Date received
- 2007-08-29
- 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
- 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 9 FC | SURGICAL MICROSCOPE | CARL ZEISS SURGICAL GMBH, | EPT | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-08-29 | 0 | 1. O |
Event Narratives#
N
Patient 1
A FACTORY TRAINED SERVICE REPRESENTATIVE CONDUCTED A SITE VISIT AND FOUND THAT THE SAFETY SCREW WAS LOOSE. THE REPRESENTATIVE REPLACED A CAP WITH INTEGRATED SAFETY SCREW, THEN SECURED BOTH THE CAP AND THE SAFETY SCREW. THE REP VERIFIED OPTICAL AND MECHANICAL FUNCTIONS, THEN REVIEWED FUNCTIONS WITH DR. NO SERVICE HAD PREVIOUSLY BEEN PERFORMED BY ZEISS PERSONNEL ON THIS MICROSCOPE. IT IS BELIEVED THAT THE CAUSE OF THE REPORTED EVENT WAS A LOOSE SECURING SCREW. THE MICROSCOPE SYSTEM'S USER'S MANUAL CONTAINS A CAUTION TO USERS TO VERIFY BEFORE EACH SURGERY THAT THE SECURING SCREW HAS BEEN FIRMLY TIGHTENED.