FDA Adverse Event
Other
Summary report: N
CLARUS LASE
MDR report key: 392057
·
Received April 29, 2002
Report
- Report Number
- 2183911-2002-00001
- Event Type
- Other
- Date Received
- April 29, 2002
- Date of Event
- March 26, 2002
- Report Date
- April 26, 2002
- Manufacturer
- CLARUS MEDICAL, LLC.
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TIP OF LASE DEVICE, WHICH IS MADE OF STAINLESS STEEL, CLASS FIBER FOR IMAGE AND PLASTIC FIBER FOR ILLUMINATION AND EPOXY, WAS LEFT IN THE PATIENT. THE LOCATION OF THE TIP AFTER SURGERY WAS INSIDE OF THE SPINAL DISC IN THE LUMAR AREA OF THE SPINE. THE EXACT LEVEL IS NOT KNOWN BY THE MANUFACTURER. MANUFACTURER WAS TOLD THE PATIENT HAD DEGENERATIVE DISC DISEASE. NO PATIENT INJURY WAS REPORTED TO THE MFR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARUS LASE | ENDOSCOPIC DISECTOMY DEVICE | GEX | CLARUS MEDICAL, LLC. | 1100-002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |