MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-03-14 for OPERON D820 3401-065 manufactured by Berchtold Gmbh & Co. Kg.
[2632488]
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.
Patient Sequence No: 1, Text Type: D, B5
[9767083]
The head section was evaluated by a berchtold field service representative on january 20, and found to be operating as designed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010153-2012-00001 |
| MDR Report Key | 2498312 |
| Report Source | 06 |
| Date Received | 2012-03-14 |
| Date of Report | 2012-03-12 |
| Date of Event | 2012-01-17 |
| Date Mfgr Received | 2012-01-19 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS MANNARINO, U.S. AGENT |
| Manufacturer Street | 1950 HANAHAN ROAD |
| Manufacturer City | CHARLESTON SC 29406 |
| Manufacturer Country | US |
| Manufacturer Postal | 29406 |
| Manufacturer Phone | 8002435135 |
| Manufacturer G1 | BERCHTOLD GMBH & CO. KG |
| Manufacturer Street | LUDWIGSTALER STR. 25 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPERON |
| Generic Name | SURGICAL TABLE |
| Product Code | FWY |
| Date Received | 2012-03-14 |
| Model Number | D820 |
| Catalog Number | 3401-065 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD GMBH & CO. KG |
| Manufacturer Address | LUDWIGSTALER STR. 25 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-14 |