MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-03-01 for ALPHA OMEGA TAPERED STR-000076-10 manufactured by Alpha Omega Engineering Ltd..
[101274181]
Alpha omega's disposable sterile cannula for neurosurgery, model: tapered cannula (pn str-000076-10) was used during a routine placement of a dbs electrode neurosurgery procedure. Following the neurosurgery, the user complained that he noticed unusual hemorrhage which he suspects that was caused by the use of alpha omega's disposable sterile cannula. No other adverse neurosurgery outcomes were reported. No remedial action was reported by the healthcare facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615126-2018-00001 |
| MDR Report Key | 7306330 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-03-01 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-01-31 |
| Device Manufacturer Date | 2017-11-15 |
| Date Added to Maude | 2018-03-01 |
| 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 Street | MOUNT PRECIPICE |
| Manufacturer City | NAZARETH, 1612102 |
| Manufacturer Country | IS |
| Manufacturer Postal | 1612102 |
| Manufacturer G1 | ALPHA OMEGA ENGINEERING LTD. |
| Manufacturer Street | MOUNT PRECIPICE |
| Manufacturer City | NAZARETH, 1612102 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 1612102 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHA OMEGA |
| Generic Name | STERILE DISPOSABLE CANNULA |
| Product Code | GZL |
| Date Received | 2018-03-01 |
| Model Number | TAPERED |
| Catalog Number | STR-000076-10 |
| Lot Number | 30106 |
| Device Expiration Date | 2019-12-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPHA OMEGA ENGINEERING LTD. |
| Manufacturer Address | MOUNT PRECIPICE NAZARETH, 1612102 IS 1612102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-01 |