FDA Adverse Event
Other
Summary report: N
QUANTUM 2 SYSTEM
MDR report key: 2001129
·
Received February 18, 2011
Report
- Report Number
- 2951580-2011-00010
- Event Type
- Other
- Date Received
- February 18, 2011
- Date of Event
- January 10, 2011
- Report Date
- February 18, 2011
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K082666
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION HAS BEEN REQUESTED, BUT TO DATE HAS NOT BEEN PROVIDED. FROM SECTION THE DEVICE WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS AND A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
A CLINICAL INCIDENT INVOLVING A QUANTUM 2 SYSTEM WAS REPORTED TO ARTHROCARE CORPORATION. REPORTEDLY, THE CONTROLLER KEPT ALARMING DURING SURGERY AND CAUSED A DELAY IN SURGERY OF APPROXIMATELY 30 MINUTES. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT AND WITHOUT PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUANTUM 2 SYSTEM | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |