MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for SITUATE 01-0027 manufactured by Mitg - Rf Surgical Systems.
[142878046]
One device was received for evaluation. The returned sample met specification as received. The visual inspection found no notable conditions. The investigation found the device to function normally and within specifications. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142878047]
According to the reporter, intra-operatively, the console was providing false readings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005883396-2019-00024 |
| MDR Report Key | 8524631 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-17 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2019-04-01 |
| Date Added to Maude | 2019-04-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | MITG - RF SURGICAL SYSTEMS |
| Manufacturer Street | 2101 FARADAY |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SITUATE |
| Product Code | MMP |
| Date Received | 2019-04-17 |
| Returned To Mfg | 2019-04-10 |
| Model Number | 01-0027 |
| Catalog Number | 01-0027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MITG - RF SURGICAL SYSTEMS |
| Manufacturer Address | 2101 FARADAY CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-17 |