FDA Adverse Event
Malfunction
Summary report: N
XTREMEBEAM
MDR report key: 2571289
·
Received September 7, 2010
Report
- Report Number
- 3005775121-2010-00001
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Date of Event
- June 23, 2010
- Report Date
- July 23, 2010
- Manufacturer
- BFW INC.
- Product Code
- FST
- PMA / PMN Number
- K093386
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING WORK ORDER NOW INCLUDES THE ADDITION OF LOCK TITE ON IRIS-ADJUSTING POST TO ALL HEADLIGHTS WITH 100% INSPECTION OF UNITS PRIOR TO SHIPMENT.
Description of Event or Problem · 1
(B)(6). INCIDENT: IRIS-ADJUSTING POST FELL FROM FIBER OPTIC HEADLIGHT OPTIC INTO PATIENT'S BODY CAVITY. POST WAS RETRIEVED FROM PATIENT. HEADLIGHT HAS JUST BEEN RECEIVED FROM FACILITY ACTION TAKEN BY FACILITY: HOSPITAL HAS FILED AN INTERNAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XTREMEBEAM | FIBER OPTIC HEADLIGHT | FST | BFW INC. | BFW 9855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |