MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2009-09-22 for REPAIR TPS OSC SAW 5100031000R manufactured by Stryker Instruments Kalamazoo.
[1175705]
It was reported that before a surgical procedure, a black fluid came out of the device. There was no reported pt or user injury, and the procedure was completed successfully with another device that was on hand.
Patient Sequence No: 1, Text Type: D, B5
[8419394]
The device has been received at the manufacturer, and a quality evaluation will be conducted. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2009-00554 |
| MDR Report Key | 1505237 |
| Report Source | 01,07 |
| Date Received | 2009-09-22 |
| Date of Report | 2009-08-24 |
| Date of Event | 2009-08-24 |
| Date Mfgr Received | 2009-08-24 |
| Device Manufacturer Date | 2006-02-24 |
| Date Added to Maude | 2009-12-28 |
| 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 | REPAIR TPS OSC SAW |
| Generic Name | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC |
| Product Code | DZH |
| Date Received | 2009-09-22 |
| Returned To Mfg | 2009-08-24 |
| Catalog Number | 5100031000R |
| 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 | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-22 |