FDA Adverse Event
Malfunction
Summary report: N
OUTPATIENT II
MDR report key: 1077323
·
Received May 20, 2008
Report
- Report Number
- 2018492-2007-00026
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Date of Event
- October 25, 2007
- Report Date
- November 19, 2007
- Manufacturer
- BURTON MEDICAL PRODUCTS
- Product Code
- FCQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LIGHT WAS IN USE WHEN IT SEPARATED FROM THE DOWN TUBE AT THE EXTENSION ARM JUNCTION. NO INJURIES OCCURRED AND THE LIGHT WAS REPLACED. THE UNIT SHOWS SIGNS OF EXCESSIVE WEAR AND TEAR. THE ARM WAS CONTINUALLY FATIGUED BY THE END-USER PUSHING THE EXTENSION ARM UP INTO THE PIVOT SUPPORT. THIS CAUSED THE EXTENSION ARM TO SEPARATE AND DROP. THE END-SUER SHOULD HAVE NOTICED THE DAMAGE OCCURRING AT THE JUNCTION AND HAD THE LIGHT REPAIRED PRIOR TO THE INCIDENT.
Description of Event or Problem · 1
LIGHT FELL AT EXTENSION ARM JUNCTION DURING PROCEDURE. NO INJURIES OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OUTPATIENT II | DIAGNOSTIC LIGHT | FCQ | BURTON MEDICAL PRODUCTS | OPII |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |