FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN CUSA EXCEL
MDR report key: 3140134
·
Received May 29, 2013
Report
- Report Number
- 3006697299-2013-00041
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Report Date
- May 29, 2013
- Manufacturer
- INTEGRA LIFESCIENCES IRELAND LIMITED
- Product Code
- LFL
- PMA / PMN Number
- K981262
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
A CUSA EXCEL CONSOLE WAS REPORTED TO HAVE LEAKED IN THE OPERATING ROOM DURING A PROCEDURE. THE SURGERY WAS DELAYED 2.5 HOURS AND THERE WAS NO PATIENT INJURY OR DEATH. THE REPORTER WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION SUCH AS CATALOGUE NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235655 | UNKNOWN CUSA EXCEL | ULTRASONIC SURGICAL PRODUCTS | LFL | INTEGRA LIFESCIENCES IRELAND LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |