FDA Adverse Event
Other
Summary report: N
UROVIEW 2600 X-RAY SYSTEM
MDR report key: 284163
·
Received June 27, 2000
Report
- Report Number
- 1720753-2000-00005
- Event Type
- Other
- Date Received
- June 27, 2000
- Date of Event
- June 21, 2000
- Report Date
- June 27, 2000
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE UROLOGY CASE WAS FINISHING WITH THE PT EXTENDED OVER THE URINE TRAY. THE NURSE INSTALLED THE TABLE LEG EXTENSION IN ORDER TO MOVE THE PT OFF THE TABLE. IN THE PROCESS OF INSTALLING THE LEG EXTENSION THE PT'S FINGER WAS CAUGHT BETWEEN THE TABLE AND THE LEG EXTENSION MOUNTNG BRACKET. THE PT'S FINGER WAS CUT AND BROKEN. THIS WAS AN OPERATOR ERROR ACCORDING TO THE REPORTING HOSP. ALL APPLICABLE PERSONNEL AT THE HOSP WERE MADE AWARE OF THIS OCCURRENCE AND CAUTIONED TO TAKE ADD'L CARE WHEN INSTALLING THE LEG EXTENSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UROVIEW 2600 X-RAY SYSTEM | UROLOGY TABLE X-RAY SYSTEM | JAA | GE OEC MEDICAL SYSTEMS, INC. | 2600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |