MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-04 for ALPHA OMEGA 366-000024-10 manufactured by Alpha Omega Engineering Ltd..
[79034172]
Shipping error.
Patient Sequence No: 1, Text Type: N, H10
[79034173]
The user reported to alpha omega about an attempt to using wrong deep brain recording electrode, during neurosurgery procedure, for placement dbs electrode. No proper replacement electrode was available; therefore the neurosurgeon has decided to terminate the dbs neurosurgery procedure. No injury to the patient was reported. The complaint investigation conclusion indicated that the order processing procedure was not followed by an employee, which led to the shipping of a wrong electrode. A corrective action was implemented by alpha omega to eliminate reoccurrence of such cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615126-2017-00002 |
| MDR Report Key | 6685303 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-07-04 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2015-12-23 |
| Date Added to Maude | 2017-07-04 |
| 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 Phone | 46563327 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHA OMEGA |
| Generic Name | NEUROPROBE |
| Product Code | GZL |
| Date Received | 2017-07-04 |
| Catalog Number | 366-000024-10 |
| Lot Number | 20528 |
| Device Expiration Date | 2017-12-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-07-04 |