MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for SITUATE 01-0031 manufactured by Mitg - Rf Surgical Systems.
[99781804]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[99781805]
According to the reporter, the device would not detect the sponges. No patient involved. No further information available.
Patient Sequence No: 1, Text Type: D, B5
[105905859]
Evaluation summary: one device was received for evaluation. This device had not been used in the treatment or diagnosis of the patient. The returned product met specification as received. Visual inspection found no defects. The reported condition was not confirmed. The investigation found all the coils passed testing on the tester. The mat was plugged into the console detected sponges. 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
| Report Number | 3005883396-2018-00014 |
| MDR Report Key | 7245776 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-03-02 |
| Date Mfgr Received | 2018-02-14 |
| Date Added to Maude | 2018-02-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| 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 |
| Generic Name | ERYTHROCYTE SUSPENSION, MULTI SPECIES, SEROLOGICAL REAGENT AND EQUIPMENT |
| Product Code | LHW |
| Date Received | 2018-02-06 |
| Returned To Mfg | 2018-01-31 |
| Model Number | 01-0031 |
| Catalog Number | 01-0031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-02-06 |