FDA Adverse Event
Injury
Summary report: N
NEUROBLATE LASER DELIVERY PROBE
MDR report key: 3161941
·
Received May 28, 2013
Report
- Report Number
- 3005840757-2013-00007
- Event Type
- Injury
- Date Received
- May 28, 2013
- Date of Event
- April 29, 2013
- Report Date
- May 28, 2013
- Manufacturer
- MONTERIS MEDICAL INC.
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT IS UNCLEAR IF LASER DELIVERY PROBE IS RELATED TO REPORTED HEMORRHAGE. DEVICE WILL NOT BE RETURNED FOR ANALYSIS. MONTERIS WILL TREND COMPLAINTS OF THIS NATURE.
Description of Event or Problem · 1
AS REPORTED, AFTER CREATING OPENING IN THE SKULL USING ANOTHER COMPANY'S DRILL, NEUROBLATE LASER DELIVERY PROBE WAS INSERTED INTO PT. FIRST MR SCAN INDICATED A HEMORRHAGE, CONFIRMED BY A SECOND MR SCAN. NEUROBLATE PROCEDURE WAS ABORTED AND PT RECEIVED A VENTRICULOSTOMY. PT CAME OUT OF VENTRICULOSTOMY WITH NO LONG-TERM NEGATIVE EFFECTS. IT IS NOT KNOWN WHEN THE HEMORRHAGE OCCURRED, OR IF IT WAS CAUSED BY THE INITIAL SKULL ACCESS, THE NEUROBLATE LASER DELIVERY PROBE, OR ANOTHER FACTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233136 | NEUROBLATE LASER DELIVERY PROBE | POWERED LASER SURGICAL INSTRUMENT | GEX | MONTERIS MEDICAL INC. | 02005-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |