MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-11-07 for BERCHTOLD OPERON SCANDIA SL 3235 manufactured by Berchtold Holding Gmbh.
[19077187]
A section of surgical table came apart during a procedure. The patient slid to the floor while strapped to the cushioned section. No injuries were found on the patient. Patient was placed in an unapproved position and table was set up incorrectly for procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220685-2002-00004 |
| MDR Report Key | 427813 |
| Report Source | 06 |
| Date Received | 2002-11-07 |
| Date of Report | 2002-11-05 |
| Date of Event | 2002-10-07 |
| Date Facility Aware | 2002-10-08 |
| Report Date | 2002-11-07 |
| Date Reported to FDA | 2002-11-07 |
| Date Reported to Mfgr | 2002-11-07 |
| Device Manufacturer Date | 2002-07-01 |
| Date Added to Maude | 2002-11-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | H |
| Manufacturer Street | LUDWIGASTALER STRASSE 27 POSTFACH 4047 |
| Manufacturer City | TUTTLINGEN D-78505 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-78505 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERCHTOLD OPERON |
| Generic Name | SURGICAL TABLE |
| Product Code | FSE |
| Date Received | 2002-11-07 |
| Model Number | SCANDIA SL |
| Catalog Number | 3235 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 416825 |
| Manufacturer | BERCHTOLD HOLDING GMBH |
| Manufacturer Address | LUDWIGSTALER STRASSE 27 POSTFACH 4047 TUTTLINGEN GM D-78505 |
| Baseline Brand Name | BERCHTOLD OPERON |
| Baseline Generic Name | SURGICAL TABLE |
| Baseline Model No | SCANDIA SL |
| Baseline Catalog No | 3235 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-11-07 |