FDA Adverse Event
Other
Summary report: N
ULTRA 360 PATIENT POSITIONING SYSTEM
MDR report key: 1404116
·
Received June 16, 2009
Report
- Report Number
- 3004608878-2009-00026
- Event Type
- Other
- Date Received
- June 16, 2009
- Report Date
- June 16, 2009
- Product Code
- FWZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION. THE INVESTIGATION WILL INCLUDE AN INSPECTION AND TESTING OF THE RETURNED DEVICE.
Description of Event or Problem · 1
THE REPORTER STATED, MAYFIELD 360 BASE UNIT DOES NOT THREAD INTO THE CRWMA ADAPTOR WITHOUT BECOMING STUCK. ON (B)(6), 2009, SECONDARY REPORTER STATED, THE EVENT RESULTED IN A 45 MINUTE TO AN HOUR DELAY IN TWO SEPARATE PATIENT SURGICAL PROCEDURES. THE EVENT OCCURRED DURING TWO SEPARATE STEREOTACTIC BRAIN BIOPSY PROCEDURES. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRA 360 PATIENT POSITIONING SYSTEM | NA | FWZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |