FDA Adverse Event
Malfunction
Summary report: N
SURGICAL LASER TECHNOLOGIES SAPPHIRE LASER TIP
MDR report key: 22662
·
Received June 9, 1995
Report
- Report Number
- 22662
- Event Type
- Malfunction
- Date Received
- June 9, 1995
- Date of Event
- May 19, 1995
- Report Date
- May 24, 1995
- Manufacturer
- SURGICAL LASER TECHNOLOGIES, INC.
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
UPON REMOVAL OF FIBER FROM SCOPE, SAPPHIRE LASER TIP NOTED TO BE MISSING FROM METAL COLLAR. NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGICAL LASER TECHNOLOGIES SAPPHIRE LASER TIP | GEX | SURGICAL LASER TECHNOLOGIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |