MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-02-26 for ULTRASONIC GENERATOR 230V CE OS3000 manufactured by Orthofix Srl.
[137130853]
On july 2017 orthofix (b)(4) acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision. Therefore, orthofix (b)(4) 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 generator and one handset were received by orthofix (b)(4) on 18 february 2019. The second handset is still not returned. Orthofix (b)(4) is strictly in contact with the local distributor to have the device concerned. The technical evaluation will be performed as soon as all devices are available. 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 (b)(4) will provide a follow up report. Orthofix (b)(4) continues monitoring the devices on the market. Please kindly refer also to mfr report number 9680825-2019-00011 and mfr report number 9680825-2019-00012.
Patient Sequence No: 1, Text Type: N, H10
[137130854]
The information provided by the local distributor indicates: hospital name: (b)(6) hospital. Surgeon name: mr (b)(6). Date of initial surgery: (b)(6) 2019. Body part to which device was applied: hip revision. Surgery description: revision epr. Patient information: female. Problem observed during: clinical use on patient/intraoperative. Type of problem: device functional problem. Event description: "staff could not be certain if the handpiece or console was shorting out. " the complaint report form also indicates: the device failure did not have any adverse effects to patient. The initial surgery was completed with the device. The event led to a clinically relevant increase in the duration of the surgical procedure. 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. On (b)(6) 2019, orthofix (b)(4) received the following additional information: "i think it took us extra hour to hour and a half to finish the case". (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00010 |
| MDR Report Key | 8369397 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-02-26 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-03-14 |
| Date Added to Maude | 2019-02-26 |
| 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 | ULTRASONIC GENERATOR 230V CE |
| Generic Name | ULTRASONIC GENERATOR 230V CE |
| Product Code | JDX |
| Date Received | 2019-02-26 |
| Returned To Mfg | 2019-02-18 |
| Model Number | OS3000 |
| Catalog Number | OS3000 |
| Lot Number | 3G4013 |
| 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 | 2019-02-26 |