FDA Adverse Event
Malfunction
Summary report: N
TERUMO STERNAL SAW II
MDR report key: 4001794
·
Received June 30, 2014
Report
- Report Number
- 1828100-2014-00551
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- May 30, 2014
- Report Date
- December 4, 2015
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- GFA
- PMA / PMN Number
- K935391
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY (TESTING), THE STERNAL SAW MOTOR WAS FROZEN. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378844 | TERUMO STERNAL SAW II | STERNAL SAW II | GFA | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 15670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |