FDA Adverse Event
Injury
Summary report: N
ALPHA OMEGA
MDR report key: 6685303
·
Received July 4, 2017
Report
- Report Number
- 9615126-2017-00002
- Event Type
- Injury
- Date Received
- July 4, 2017
- Date of Event
- June 1, 2017
- Report Date
- June 30, 2017
- Manufacturer
- ALPHA OMEGA ENGINEERING LTD.
- Product Code
- GZL
- PMA / PMN Number
- K052527
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHIPPING ERROR.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465735 | ALPHA OMEGA | NEUROPROBE | GZL | ALPHA OMEGA ENGINEERING LTD. | 20528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |