FDA Adverse Event
Injury
Summary report: N
RBLF LASER FIBER
MDR report key: 2159041
·
Received March 10, 2006
Report
- Report Number
- MW5021284
- Event Type
- Injury
- Date Received
- March 10, 2006
- Date of Event
- January 19, 2004
- Report Date
- February 14, 2006
- Manufacturer
- LASER PERIPHERALS, LLC
- Product Code
- LNK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER STATES FIBER BROKE MID-SHAFT OF FIBER AT LOCATION OF PROXIMAL END OF ENDOSCOPE. PHYSICIAN WAS "BURNED" AT TIME OF FRACTURE. THE INJURY TO PHYSIICAN WAS MINOR AND HE DID CONTINUE PROCEDURE WITH ANOTHER FIBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RBLF LASER FIBER | SURGICAL LASER FIBER | LNK | LASER PERIPHERALS, LLC | RBLF-200 | LP-299 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UK | Other |