MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-01-16 for ULTRASONIC GENERATOR 230V CE OS3000 manufactured by Orthofix Srl.
[135183068]
Technical evaluation: 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. The returned devices, received on december 24, 2018, were examined by orthofix (b)(4) quality engineering department. The devices were visually checked by orthofix (b)(4) quality engineering department and then sent to the supplier, (b)(4), for the functional check. The visual check evidenced as follows: the case frame of the ultrasonic generator, device code os3000 serial number (b)(4), is damaged. The connector of the cable code ch300 lot ch2310 is strongly damaged. The functional check evidenced as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly with the exception of the led of the channel 1 that is burned. The cable, device code ch300 batch ch2310, is not functioning properly. The sealing is lost from the connector and the earth bond test failed. The results of the technical evaluation concluded as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly. The failure found on the led of the channel 1 can be considered normal wear and tear of the electrical components. The failure found on the cable, device code ch300 batch ch2310, is most likely attributable to an accidental crushing of the connector. Medical evaluation: the information made available on the case together with the results of the technical investigation were sent to our medical evaluator. Please find below an extract of the medical evaluation performed: "in this case an oscar generator and cable were found to be not functional. We do not know what the intended procedure was. The operation had to be performed with one handset and cable and one channel. All the normal procedures would have been possible but it all took longer than was expected, to the extent that the operating time was extended by a clinically relevant, but unspecified amount. No further information is provided. The technical report has highlighted 2 small marks on the generator casing. The generator functions perfectly well with one exception: the led illuminating the channel 1 screen has blown and does not work. It is therefore impossible to use channel 1. In addition to this the associated cable is 'unusable' because of a damaged connector and a failed earth bond test. The connector has been damaged due to rough handling, and the led failed because these components do fail eventually. The operation was completed as planned but considerable time (unspecified) was lost". Final comments: based on the results of the technical evaluation an on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is due to normal wear and tear of the electrical components of the generator. Orthofix (b)(4) continues monitoring the devices on the market. Please also kindly refer to mfr report 9680825-2019-00002.
Patient Sequence No: 1, Text Type: N, H10
[135183069]
The information provided by the local distributor indicates: devices involved: 1 ultrasonic generator 230v ce code os3000 batch (b)(4) (mfr report) and 1 cable code ch300 batch ch2310 (mfr 9680825-2019-00002). Hospital name: (b)(6) hospital. Surgeon's name: no response. Date of initial surgery: (b)(6) 2018. Body part to which device was applied: no response. Surgery description: other. Patient information: no response. Problem observed during: clinical use on patient/intraoperative. Type of problem: device functional problem. Event description: "it appears 1 x handset is not functioning and 1 x cable is not working. It seems that friday's case was an exceptional one and not the case for oscar to fail in. They have a 'steward's inquiry' going on questioning why a set fresh from service did not function in a critical case. Whilst staff were calm today it seems red faces and bad tempers were abound on friday". The complaint 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. Information about patient current health condition is not available. No other information was provided. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00001 |
| MDR Report Key | 8252636 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-12-07 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2019-01-16 |
| 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 | 2019-01-16 |
| Returned To Mfg | 2018-12-24 |
| Model Number | OS3000 |
| Catalog Number | OS3000 |
| Lot Number | 3G4016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-01-16 |