MAUDE report
MAUDE report 10483: ELECTROSURGICAL UNIT
Malfunction · received Dec 14, 1993 · BIRTCHER MEDICAL SYSTEMS
Key facts
| MDR report key | 10483 |
|---|---|
| Report number | MW1000111 |
| Event type | Malfunction |
| Brand name | ELECTROSURGICAL UNIT |
| Model number | 4400 |
| Manufacturer | BIRTCHER MEDICAL SYSTEMS |
| Date received by FDA | Dec 14, 1993 |
| Report date | Nov 30, 1993 |
| Report source | Maude |
At a glance
- None Device problems coded
- 100–999 MAUDE reports for this brand
- 1–9 Death reports for this brand
- 10–99 Injury reports for this brand
- No Adverse event flagged
- Yes Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: