MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2010-04-01 for TERUMO STERNAL SAW II 15670 manufactured by Terumo Cardiovascular Systems Corp..
[1577146]
During use of the device for a surgical procedure, the user reported, the sternal saw did not have enough power to cut the bone. An alternate device was employed to conclude the procedure. The user reported, the surgical procedure was completed successfully, and there was no adverse consequence to the pt as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[8543093]
Evaluation in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2010-00172 |
| MDR Report Key | 1650454 |
| Report Source | 00,06 |
| Date Received | 2010-04-01 |
| Date of Report | 2010-04-01 |
| Date of Event | 2010-03-05 |
| Date Mfgr Received | 2010-03-05 |
| Date Added to Maude | 2010-04-20 |
| 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 RD. |
| 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 II |
| Generic Name | STERNUM SAW MOTOR |
| Product Code | DWH |
| Date Received | 2010-04-01 |
| Returned To Mfg | 2010-03-10 |
| Model Number | 15670 |
| Catalog Number | 15670 |
| 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 | 2010-04-01 |