FDA Adverse Event
Other
Summary report: N
SAPHYRE PROBE II 90 DEG. SUCTION
MDR report key: 1278371
·
Received December 22, 2008
Report
- Report Number
- 1216828-2008-00006
- Event Type
- Other
- Date Received
- December 22, 2008
- Date of Event
- November 14, 2008
- Report Date
- November 14, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIVISION
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. (B) (4).
Description of Event or Problem · 1
DURING KNEE ARTHROSCOPY PROCEDURE, ABLATION OCCURRED NOT ONLY AT THE TIP OF THE PROBE BUT FROM THE TIP TO THE BIPOLAR PLATE. THE PT EXPERIENCED EXCESSIVE SOFT TISSUE BURN. NO OTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAPHYRE PROBE II 90 DEG. SUCTION | PROBE | GEI | SMITH & NEPHEW INC., ENDOSCOPY DIVISION | 7210111 | 120216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |