FDA Adverse Event
Injury
Summary report: N
SLT-SURGICAL LASER TECHNOLOGIES
MDR report key: 140863
·
Received December 22, 1997
Report
- Report Number
- MW1012708
- Event Type
- Injury
- Date Received
- December 22, 1997
- Date of Event
- December 22, 1997
- Report Date
- December 22, 1997
- Manufacturer
- SURGICAL LASER TECHNOLOGIES, INC.
- Product Code
- LLO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
LASER BRONCHOSCOPY PROCEDURE, 1.8 FIBER USED PER GUIDELINES, SURGEON REQUESTED ROUND TIP, NURSE SCREWED TIP ON SECURELY. WHEN SURGEON PULLED FIBER OUT OF SCOPE, THE ENTIRE "SCREWED ON" TIP & A PIECE OF THE FIBER REMAINED IN THE BRONCHUS. SURGEON WAS ABLE TO RETRIEVE THE TIP & ATTACHMENT FROM THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLT-SURGICAL LASER TECHNOLOGIES | FIBER DELIVERY SYSTEM | LLO | SURGICAL LASER TECHNOLOGIES, INC. | * | 112009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |