FDA Adverse Event
Other
Summary report: N
LASE
MDR report key: 415043
·
Received August 29, 2002
Report
- Report Number
- 415043
- Event Type
- Other
- Date Received
- August 29, 2002
- Date of Event
- August 15, 2002
- Report Date
- August 26, 2002
- Manufacturer
- CLARUS MEDICAL, LLC.
- Product Code
- GEX
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WHILE PERFORMING PROCEDURE, THE LASER FIBER CRACKED. DR WAS BURNED ON THEIR RIGHT HAND INDEX FINGER, 2ND FINGER AND THUMB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LASE | ENDOSCOPIC DISCECTOMY | GEX | CLARUS MEDICAL, LLC. | 1100-002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |