MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-05-02 for ULTRASONIC GENERATOR 230V CE OS3000 manufactured by Orthofix Srl.
[144122247]
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 devices involved in this event were manufactured by orthosonics ltd. Technical evaluation: the devices involved in this event have not yet been received by orthofix (b)(4). Orthofix (b)(4) is strictly in contact with the local distributor to have the devices concerned. The technical evaluation will be performed as soon as the devices become available. Medical evaluation: the information made 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 technical 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 also kindly refer to mfr reports 9680825-2019-00031/32/33/34/35. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144122248]
The information provided by the local distributor indicates: products code: 1 handset code oh300/2 batch 3h4026 (mfr report 9680825-2019-00031); 1 handset code oh300/2 batch 3h4033 (mfr report 9680825-2019-00032); 1 cable code ch300 batch ch2299 (mfr report 9680825-2019-00033); 1 cable code ch300 batch ch2298 (mfr report 9680825-2019-00034); 1 ultrasonic generator code os3000 batch 3g4014 (mfr report 9680825-2019-00035); 1 ultrasonic generator code os3000 batch 3g4010 (mfr report 9680825-2019-00036). Hospital name: (b)(6); surgeon name: (b)(6); date of initial surgery: (b)(6) 2019; body part to which device was applied: no response; surgery description: other; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem. Event description: "handset not functioning correctly, serial numbers provided over the phone (b)(4), and cables (b)(4). They were tried with both generators (b)(4). The patient was having a revision hip replacement when the said equipment stopped working. The procedure had to be abandoned and the patient had to be rescheduled for today ((b)(6) 2019) to finish the operation". The complaint report form also indicated: the device failure had adverse effects on patient; the initial surgery was not completed with the device; a replacement device was not immediately available to complete surgery (the surgery had to be abandoned and the patient had to come back to theatre on (b)(6) 2019 to finish the procedure). The event led to a clinically relevant increase in the duration of the surgical procedure (the patient had another operation on another date, subjecting the patient to another round of anaesthesia and days in hospital). An additional surgery was required (performed on (b)(6) 2019). 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: the patient has been reschedule to have the second stage of his surgery today (b)(6) 2019. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00036 |
| MDR Report Key | 8573038 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-05-02 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-07-03 |
| Date Added to Maude | 2019-05-02 |
| 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, 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 | 2019-05-02 |
| Returned To Mfg | 2019-05-09 |
| Model Number | OS3000 |
| Catalog Number | OS3000 |
| Lot Number | 3G4010 |
| 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, 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-02 |