D
Patient 1
USER FACILITY REPORTED THAT A PATIENT RECEIVED A 2ND DEGREE BURN DURING SPINE SURGERY.
MAUDE MDR 832515
- MDR report key
- 832515
- Report number
- 2431026-2007-00005
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-03-21
- Date received
- 2007-03-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KENT JONES
- Address
- 5160 HACIENDA DRIVE 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 | 1290-983 | * | * | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-03-28 | 0 | 1. O |
Event Narratives#
N
Patient 1
INITIALLY, THE USER FACILITY ALLEGED THAT THE SURGICAL MICROSCOPE INCREASED TO 100% INTENSITY IN AN UNCONTROLLED MANNER, WITHOUT INPUT FROM THE USER. THE INSTRUMENT WAS SUBSEQUENTLY INSPECTED BY A FIELD SERVICE REPRESENTATIVE AND FOUND TO MEET PRODUCT SPECIFICATION. NO INSTRUMENT FAILURE COULD BE FOUND THAT WOULD CAUSE AN UNCONTROLLED CHANGE OF THE INTENSITY. THE SENIOR SURGEON CONSIDERS THE INCIDENT TO BE THE RESULT OF USER ERROR AND NOT A DEVICE MALFUNCTION.