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 |