MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-07-27 for CASTVAC W/8 FOOT HOSE AND MOBILE STAND 0986000000 manufactured by Stryker Instruments Kalamazoo.
[15020696]
It was reported that the castvac began smoking during a procedure. The case was completed with another device. There was no medical intervention required. There were no adverse consequences reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[15295951]
The castvac was received at the mfr for eval, and the reported condition of the device smoking was duplicated. Based on the investigation details, the likely cause was a damaged power cord assembly, which was replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2012-02881 |
| MDR Report Key | 2698484 |
| Report Source | 06 |
| Date Received | 2012-07-27 |
| Date of Report | 2012-07-06 |
| Date of Event | 2012-07-05 |
| Date Mfgr Received | 2012-07-06 |
| Device Manufacturer Date | 2001-02-19 |
| Date Added to Maude | 2012-11-19 |
| 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 | GREGORY GOHL |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASTVAC W/8 FOOT HOSE AND MOBILE STAND |
| Product Code | LGH |
| Date Received | 2012-07-27 |
| Returned To Mfg | 2012-07-09 |
| Catalog Number | 0986000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-27 |