FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 727322
·
Received May 4, 2006
Report
- Report Number
- 2020550-2006-00024
- Event Type
- Other
- Date Received
- May 4, 2006
- Date of Event
- April 7, 2006
- Report Date
- May 1, 2006
- Manufacturer
- OMNI CORPORATION
- Product Code
- FET
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT WAS ANESTHESIZED FOR A URETHROTOMY PROCEDURE. BEFORE THE PROCEDURE STARTED THE VIDEO CART'S ARTICULATING ARM, WHICH HOLDS A FLAT PANEL MONITOR CAME OUT OF ITS SOCKET/CUP CAUSING THE ARM TO SWING FREE AND FRONT FACE OF THE MONITOR SCREEN TO FALL ON THE PATIENT'S FACE. A PAD HAD BEEN LAID ACROSS THE PATIENT'S FACE AND THE MONITOR HAD CALBE TIES ON THE MONITOR CABLES, LESSENING THE IMPACT. THE PROCEDURE WAS IMMEDIATELY TERMINATED AND THE PATIENT WAS VISUALLY EXAMINED; NO APPARENT INJURIES WERE NOTED. THE PATIENT WAS ALSO CT SCANNED AND THE RESULT WAS NEGATIVE; PATIENT CONDITION WAS GOOD. ANOTHER SURGERY HAD TO BE RESCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | VIDEO CART | FET | OMNI CORPORATION | 9601F | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 03 YR | Other |