MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-03 for ALPHA OMEGA 750-000020-00 manufactured by Alpha Omega Engineering Ltd..
[79140288]
No injury on the patient, the user immediately removed the headstage and replaced it with another headstage and continued the surgery procedure.
Patient Sequence No: 1, Text Type: N, H10
[79140289]
The headstage returned back 3 mm when it was connected to main unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615126-2017-00001 |
| MDR Report Key | 6683773 |
| Date Received | 2017-07-03 |
| Date of Report | 2017-01-06 |
| Date of Event | 2016-11-30 |
| Date Facility Aware | 2016-12-07 |
| Device Manufacturer Date | 2014-12-18 |
| Date Added to Maude | 2017-07-03 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MAYSANA MOUSA |
| Manufacturer City | NAZARETH, 1612102 |
| Manufacturer Country | IS |
| Manufacturer Postal | 1612102 |
| Manufacturer G1 | ALPHA OMEGA ENGINEERING LTD. |
| Manufacturer City | NAZARETH, 1612102 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 1612102 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALPHA OMEGA |
| Generic Name | NEURO OMEGA HEADSTAGE |
| Product Code | GZL |
| Date Received | 2017-07-03 |
| Returned To Mfg | 2016-12-07 |
| Catalog Number | 750-000020-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPHA OMEGA ENGINEERING LTD. |
| Manufacturer Address | NAZARETH INDUSTRIAL PARK BUILD MOUNT PRECIPICE NAZARETH, 1612102 IS 1612102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-03 |