MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-26 for CASTVAC W/8 FOOT HOSE AND MOBILE STAND 0986000000 manufactured by Stryker Instruments-kalamazoo.
[3741053]
The castvac w/8 foot hose and mobile stand was returned to stryker instruments for evaluation due to allegedly overheating during a procedure. It was reported that sparks were seen and a burning smell was observed. The case was completed successfully without any procedure delay. There was no medical treatment or intervention required as a result of the event and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[11170316]
The product was not returned for evaluation, so the reported events, noise and sparks, could not be confirmed in this case.
Patient Sequence No: 1, Text Type: N, H10
[18623273]
The castvac w/8 foot hose and mobile stand was returned to stryker instruments for evaluation due to allegedly overheating during a procedure. It was reported that sparks were seen and a burning smell was observed. The case was completed successfully without any procedure delay. There was no medical treatment or intervention required as a result of the event and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[18755766]
The device is available for evaluation but has not yet been received. Additional information may be submitted once the device is received and the quality investigation is complete. Additional information may be submitted once the device is received and the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2013-00926 |
| MDR Report Key | 3080512 |
| Report Source | 06 |
| Date Received | 2013-04-26 |
| Date of Report | 2013-04-11 |
| Date of Event | 2013-04-11 |
| Date Mfgr Received | 2013-09-06 |
| Device Manufacturer Date | 1996-01-20 |
| Date Added to Maude | 2013-07-01 |
| 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 | MR. KATE LONGMAN |
| 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 |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-POWERED |
| Product Code | LGH |
| Date Received | 2013-04-26 |
| Catalog Number | 0986000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-26 |