FDA Adverse Event
Other
Summary report: N
RADIOFREQUENCY DEVICE
MDR report key: 836117
·
Received April 5, 2007
Report
- Report Number
- 1216828-2007-00017
- Event Type
- Other
- Date Received
- April 5, 2007
- Date of Event
- September 14, 2005
- Report Date
- April 4, 2007
- Manufacturer
- SMITH & NEPHEW INC., - ENDOSCOPY DIVISION
- Product Code
- GXD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED AS THE SURGERIES WERE PERFORMED IN 2005 & 2006.
Description of Event or Problem · 1
RIGHT SHOULDER ARTHROSCOPY WAS PERFORMED IN 2005, USING AN ARTHROCARE WAND. EIGHTS MONTHS LATER, THE SURGEON PERFORMED A CHONDROPLASTY IN WHICH HE USED A RADIOFREQUENCY DEVICE MFG BY SMITH & NEPHEW TO REMOVE FRAYED CARTILAGE AND SMOOTH THE SURFACES OF THE DAMAGED CARTILAGE. PT UNDERWENT A 3RD PROCEDURE IN 2006, AND FURTHER LOSS OF CARTILAGE WAS OBSERVED AND THE SURGEON PERFORMED ANOTHER CHONDROPLASTY USING A SMITH & NEPHEW MEDICAL DEVICE. IT IS INDICATED THAT AS A RESULT, THE PT HAS SUSTAINED INJURY TO HER HEALTH, STRENGTH AND ACTIVITY RESULTING IN PHYSICAL DISABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIOFREQUENCY DEVICE | * | GXD | SMITH & NEPHEW INC., - ENDOSCOPY DIVISION | UNK | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |