MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-30 for SITUATE 01-0031 manufactured by Mitg - Rf Surgical Systems.
[187102896]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187102897]
According to the reporter, during a procedure, the counts were correct; however, the patient was scanned with the body scanner and it gave a detection. Scanned with the wand but was clear. The patient was then scanned again with the body scanner and still registered a detection. Scanned with the wand again and received a clear scan. The patient was x-rayed and the results were negative. The case was extended while trying to reconcile whether or not the detection was true or false.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005883396-2020-00006 |
| MDR Report Key | 9649254 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-01-30 |
| 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 | 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 | 3 |
| Brand Name | SITUATE |
| Generic Name | COUNTER, SPONGE, SURGICAL |
| Product Code | LWH |
| Date Received | 2020-01-30 |
| Model Number | 01-0031 |
| Catalog Number | 01-0031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2020-01-30 |