MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-07-06 for TERUMO STERNAL SAW I 6090 manufactured by Terumo Cardiovascular Systems Corp..
[1346720]
During preparation for use of the device for a cardiopulmonary bypass procedure, the user reported that the saw motor seized. As a result, an alternate device was employed for the procedure. The user reported the procedure was completed successfully, and there were no adverse consequences to a patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8635016]
Evaluation in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2010-00782 |
| MDR Report Key | 1749147 |
| Report Source | 05,06 |
| Date Received | 2010-07-06 |
| Date of Report | 2010-07-06 |
| Date of Event | 2010-06-16 |
| Date Mfgr Received | 2010-06-18 |
| Date Added to Maude | 2010-09-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ARICK |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7347416238 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO STERNAL SAW I |
| Generic Name | STERNUM SAW |
| Product Code | DWH |
| Date Received | 2010-07-06 |
| Returned To Mfg | 2010-06-23 |
| Model Number | 6090 |
| Catalog Number | 6090 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-06 |