MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-07-28 for OPERON D850 3260.065 manufactured by Berchtold Gmbh & Co. Kg.
[2243684]
During a surgical procedure, when the trendelenburg function button was pressed, the table top was reported to have dropped straight down between 6" - 14". There was no pt injury reported, but the procedure was aborted after the incident.
Patient Sequence No: 1, Text Type: D, B5
[9455325]
The table was evaluated by a berchtold corp. Service technician on (b)(4) 2011 after the incident at the location where the incident occurred. The table is in good physical condition. All the table functions operated as expected without problems, and the reported problem could not be duplicated. The table has been returned to the berchtold corporation facility in (b)(4) for further eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010153-2011-00001 |
| MDR Report Key | 2232940 |
| Report Source | 06 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-07-22 |
| Date of Event | 2011-06-24 |
| Date Mfgr Received | 2011-06-24 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2012-06-18 |
| 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, 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 STRASSE 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 | 2011-07-28 |
| Model Number | D850 |
| Catalog Number | 3260.065 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-07-28 |