MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2003-06-20 for OPERON SL OT-156-0075 manufactured by Berchtold Corp..
[15608533]
A patient was positioned near the short end (foot end) of the operon sl surgical table with the table in the urology configuration for 500 lbs. The patient was maneuvered from lying flat on their back to sitting in an upright position with the assistance of four nurses. The momentum of the patient's weight caused the head end of the table to lift up and the foot end to lower which resulted in the patient sliding off the table to a standing position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220685-2003-00002 |
| MDR Report Key | 467733 |
| Report Source | 06 |
| Date Received | 2003-06-20 |
| Date of Report | 2003-06-19 |
| Date of Event | 2003-05-07 |
| Date Mfgr Received | 2003-05-07 |
| Device Manufacturer Date | 2002-05-01 |
| Date Added to Maude | 2003-06-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JASON KNIGHT |
| Manufacturer Street | 1950 HANAHAN ROAD |
| Manufacturer City | CHARELSTION SC 29406 |
| Manufacturer Country | US |
| Manufacturer Postal | 29406 |
| Manufacturer Phone | 8438180125 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPERON SL |
| Generic Name | SURGICAL TABLE |
| Product Code | FWY |
| Date Received | 2003-06-20 |
| Model Number | OPERON SL |
| Catalog Number | OT-156-0075 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 456658 |
| Manufacturer | BERCHTOLD CORP. |
| Manufacturer Address | 1950 HANAHAN RD. CHARLESTON SC 29406 US |
| Baseline Brand Name | OPERON SL |
| Baseline Generic Name | SURGICAL TABLE |
| Baseline Model No | OPERON SL |
| Baseline Catalog No | OT-156-0075 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-06-20 |