FDA Adverse Event
Malfunction
Summary report: N
LAMP MODULE, XENON XL
MDR report key: 1190736
·
Received October 6, 2008
Report
- Report Number
- 1643264-2008-00021
- Event Type
- Malfunction
- Date Received
- October 6, 2008
- Date of Event
- August 15, 2008
- Report Date
- September 12, 2008
- Manufacturer
- SMITH & NEPHEW INC. - ENDOSCOPY DIV.
- Product Code
- FFS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BULB IS LOOSE INSIDE LAMP ASSEMBLY AND FILAMENT OF BULB IS DAMAGED CAUSING NO IGNITION. DAMAGE TO LAMP ASSEMBLY EITHER OCCURRED DURING SHIPPING OR WAS MISHANDLED AT CUSTOMER SITE, HOWEVER, THIS CANNOT BE CONFIRMED.
Description of Event or Problem · 1
LIGHT INTENSITY WAS LOW AND IMAGE WAS NOT CLEAR. THE BULB WAS LOOSE IN THE BOX AND LAMP HOUR METER WAS NOT INDICATING ANYTHING. SURGERY WAS ABORTED UNTIL A COMPETITOR'S LIGHT SOURCE ARRIVED AS A BACK UP ONE HOUR LATER. TIME UNDER ANESTHESIA EXTENDED DUE TO THE DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAMP MODULE, XENON XL | LAMP MODULE | FFS | SMITH & NEPHEW INC. - ENDOSCOPY DIV. | 7205351 | 53532519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |