MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-14 for ALPHA OMEGA Standard STR-020121-10 manufactured by Alpha Omega Engineering Ltd..
[117129721]
An incident was reported by "department of neurosurgery, (b)(6) university" in (b)(6) (the customer), which uses alpha omega engineering's (aoe) neuro omega system for navigation during neurosurgery for placement a dbs electrode. Aoe's cannula p/n-str-007721-10, with length 177 mm, is normally used for this neurosurgery procedure. In the reported incident, a longer identical cannula was mistakenly used (p/n- str-020121-10, with length 201. 5 mm), resulting a dipper insertion, before the mistake was realized by the customer. The two types of cannulas are used by the customer's for different head frames. The label on the cannula clearly identifies the cannula type (by part number, length and diameter). No injury medical intervention to the patient was reported by customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615126-2018-00002 |
| MDR Report Key | 7780725 |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2017-10-25 |
| Date Added to Maude | 2018-08-14 |
| 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 | 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALPHA OMEGA |
| Generic Name | STERILE DISPOSABLE CANNULA FOR MER |
| Product Code | GZL |
| Date Received | 2018-08-14 |
| Model Number | Standard |
| Catalog Number | STR-020121-10 |
| Lot Number | 29713 |
| Device Expiration Date | 2019-10-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-08-14 |