MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-08-15 for OPERON D820 3282-065 manufactured by Berchtold Gmbh & Co. Kg.
[17605295]
During a surgical procedure with a pt on the table, and utilizing a davinci robot, the table was reported to have moved from a trendelenburg position to a level position without any activation of the level button on the hand control. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[17644302]
The table was evaluated by a berchtold field service rep on (b)(4) 2012. The problem was not duplicated. The hand control had some damage, and the height sensor required replacement, but neither of these could be directly linked to the malfunction. Both the height sensor and the hand control were replaced and the table was placed back into service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010153-2012-00004 |
| MDR Report Key | 2710960 |
| Report Source | 06,07 |
| Date Received | 2012-08-15 |
| Date of Report | 2012-08-03 |
| Date of Event | 2012-07-09 |
| Date Mfgr Received | 2012-07-09 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2012-12-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS MANNARINO, US AGENT |
| Manufacturer Street | 1950 HANAHAN RD |
| Manufacturer City | CHARLESTON SC 29406 |
| Manufacturer Country | US |
| Manufacturer Postal | 29406 |
| Manufacturer Phone | 8002435135 |
| Manufacturer G1 | BERCHTOLD GMBH |
| 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 | 2012-08-15 |
| Model Number | D820 |
| Catalog Number | 3282-065 |
| 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 | 2012-08-15 |