FDA Adverse Event
Other
Summary report: N
RAZOR2.5 WITH INTEGRATED CABLE
MDR report key: 2214019
·
Received August 3, 2011
Report
- Report Number
- 2951580-2011-00105
- Event Type
- Other
- Date Received
- August 3, 2011
- Date of Event
- July 1, 2011
- Report Date
- August 3, 2011
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K033584
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR INVESTIGATION. A F/U REPORT WILL BE PROVIDED WITH THE RESULTS OF THE INVESTIGATION.
Description of Event or Problem · 1
DURING AN ARTHROSCOPIC PROCEDURE USING A RAZOR2.5 ARTHROWAND, THE PHYSICIAN REPORTED THE TIP OF THE WAND BECAME DETACHED AND WAS LOST IN THE PT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAZOR2.5 WITH INTEGRATED CABLE | ELECTROSURGICAL CUTTING & COAGULATION DE | GEI | ARTHROCARE CORPORATION | 4U10200-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |