MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-03-12 for GEN CASEFRAME NON OPTICAL 230V OE3000B/2 manufactured by Orthofix Srl.
[138507501]
On (b)(6) 2017 orthofix srl acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision. Therefore, orthofix srl is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd. The device involved in this event was manufactured by orthosonics ltd. Technical evaluation: the device concerned was received by orthofix srl on (b)(6) 2019. The technical evaluation on the returned device is currently ongoing. Medical evaluation: the information available on the case was sent to our medical evaluator. A preliminary medical evaluation was performed and will be finalized once the results of the investigation are available. As soon as the results of the investigation are available, orthofix srl will provide a follow up report. Orthofix srl continues monitoring the devices on the market.
Patient Sequence No: 1, Text Type: N, H10
[138507502]
The information provided by the local distributor indicates: (b)(4). (b)(6). Body part to which device was applied: hip. Surgery description: hip revision. Patient information: female. Problem observed during: clinical use on patient/intraoperative. Type of problem: device functional problem. Event description: generator emitted heavy white smoke additional details: during surgery, the surgeon was using oscar console and it stopped working. Staff checked the connection of cable and turned the machine off and turned on again. When surgeon started using the oscar, heavy white smoke came out of the machine. The complaint report form also indicated: the device failure did not have any adverse effects on patient. The initial surgery was not completed with the device. A replacement device was immediately available to complete surgery. The event led to a clinically relevant increase in the duration of the surgical. Procedure: estimated delay 30-45 minutes. An additional surgery was not required. A medical intervention (outpatient clinic) was not required. Copies of the operative report are not available. Copies of the x-ray images are not available. Patient current health conditions: no response. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00018 |
| MDR Report Key | 8411113 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-03-12 |
| 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. ROBERTO DONADELLO |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer G1 | ORTHOFIX SRL |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEN CASEFRAME NON OPTICAL 230V |
| Generic Name | GEN CASEFRAME NON OPTICAL 230V |
| Product Code | JDX |
| Date Received | 2019-03-12 |
| Returned To Mfg | 2019-03-01 |
| Model Number | OE3000B/2 |
| Catalog Number | OE3000B/2 |
| Lot Number | 2G426 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, ITALY 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-12 |