FDA Adverse Event
Injury
Summary report: N
OPERON
MDR report key: 2498312
·
Received March 14, 2012
Report
- Report Number
- 8010153-2012-00001
- Event Type
- Injury
- Date Received
- March 14, 2012
- Date of Event
- January 17, 2012
- Report Date
- March 12, 2012
- Manufacturer
- BERCHTOLD GMBH & CO. KG
- Product Code
- FWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE HEAD SECTION WAS EVALUATED BY A BERCHTOLD FIELD SERVICE REPRESENTATIVE ON JANUARY 20, AND FOUND TO BE OPERATING AS DESIGNED.
Description of Event or Problem · 1
A NURSE REMOVED THE HEAD SECTION OF A SURGICAL TABLE AND PLACED IT UPSIDE DOWN ON TOP OF THE TABLE. WHILE DOING THIS, HER FINGER WAS BETWEEN THE TWO PIECES OF THE HEAD SECTION¿S RADIOLUCENT TOP, AND SHE ACCIDENTALLY HIT THE GAS SHOCK RELEASE LEVER. THIS RESULTED IN A BROKEN INDEX FINGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPERON | SURGICAL TABLE | FWY | BERCHTOLD GMBH & CO. KG | D820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |