MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for NAVIO SURGICAL SYSTEM BE/FR/DE NPFS02020 manufactured by Blue Belt Technologies.
[188488211]
It was reported that when testing the machine before a ukr procedure, when the patient was not under anesthesia yet, the navio booted fine, but said that the anspach foot pedal was disconnected. The "internal cabling/drill console error" message appeared as everything was correctly plugged in, with the message "please contact robotics customer support + (b)(4), the system must shut down". All the cables were unplugged and the machine was also shut down. This caused a delay of fewer than 30 minutes and the procedure was continued manually with s&n instrumentation. No other complications were reported. This was the first event of four in total that had happened with the same issue and another patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010266064-2020-00105 |
| MDR Report Key | 9906020 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-31 |
| 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 | MR. RICK CONFER |
| Manufacturer Street | 2828 LIBERTY AVE SUITE 100 |
| Manufacturer City | PITTSBURGH PA 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 4126833844 |
| Manufacturer G1 | BLUE BELT TECHNOLOGIES |
| Manufacturer Street | 2905 NORTHWEST BLVD STE 40 SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIO SURGICAL SYSTEM BE/FR/DE |
| Generic Name | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
| Product Code | OLO |
| Date Received | 2020-03-31 |
| Catalog Number | NPFS02020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLUE BELT TECHNOLOGIES |
| Manufacturer Address | 2905 NORTHWEST BLVD STE 40 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |