FDA Adverse Event
Malfunction
Summary report: N
TERUMO STERNAL SAW II
MDR report key: 2891008
·
Received December 20, 2012
Report
- Report Number
- 1828100-2012-01607
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- December 7, 2012
- Report Date
- December 7, 2012
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- GFA
- PMA / PMN Number
- K935391
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SERVICE REPAIR TECHNICIAN REPLACED THE SAW BLADE PROTECTOR. THE UNIT FUNCTIONS TO MANUFACTURER'S SPECIFICATIONS AND WILL BE RETURNED TO CLINICAL USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem · 1
THE SERVICE REPAIR TECHNICIAN REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SAW BLADE PROTECTOR WAS FOUND TO BE BENT. IT IS UNKNOWN AT THIS TIME HOW OR WHEN THE BLADE PROTECTOR WAS BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO STERNAL SAW II | GFA | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 5590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |