MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-04 for CASTVAC W/8 FOOT HOSE AND MOBILE STAND 0986000000 manufactured by Stryker Instruments Kalamazoo.
[2204027]
It was reported that the handpiece began smoking while the equipment was being tested. There was no patient involvement. There were no adverse consequences reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9216466]
The device was evaluated at the manufacturer for evaluation, and the reported condition of the product smoking was duplicated. Based on the investigation details, the likely cause was problems with the filter and vacuum causing the motor and pc board to fail. Those parts were each replaced along with other components.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2011-02802 |
| MDR Report Key | 2213159 |
| Report Source | 06 |
| Date Received | 2011-08-04 |
| Date of Report | 2011-07-13 |
| Date of Event | 2011-07-08 |
| Date Mfgr Received | 2011-07-13 |
| Date Added to Maude | 2011-09-27 |
| 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 AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| 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 | 2011-08-04 |
| Returned To Mfg | 2011-07-20 |
| Catalog Number | 0986000000 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2011-08-04 |