MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-23 for OPERON B 810 OT 1600175 manufactured by Berchtold Corp.
[19710832]
Investigation showed that the casting for the leg section connector was damaged. This part was bent beyond its specification and did not allow the leg section to properly connect to the table. This damaged connector contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[19844599]
The user had a shoulder chair accessory assembled to the leg section of an operon b 810 table. During the case, the leg section came detached from the table and partially fell. No pt injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220685-2010-00002 |
| MDR Report Key | 1843591 |
| Report Source | 07 |
| Date Received | 2010-09-23 |
| Date of Report | 2010-09-14 |
| Date of Event | 2010-08-17 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2011-04-28 |
| 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 | MICHAEL SASSANO |
| 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 STRASE 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 | 2010-09-23 |
| Returned To Mfg | 2010-08-30 |
| Model Number | B 810 |
| Catalog Number | OT 1600175 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERCHTOLD CORP |
| Manufacturer Address | CHARLESTON SC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-23 |