MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-01-29 for BATTERY 4115000000 manufactured by Stryker Instruments-kalamazoo.
[37094212]
This report was reported in error under the alternative report number (b)(4) on (b)(4) 2013. The device was scrapped by stryker.
Patient Sequence No: 1, Text Type: N, H10
[37094213]
It was reported that the system 4 battery allegedly overheated and emitted steam while charging at the user facility. The device was then returned to stryker instruments for evaluation where it was found to have externally and internally vented electrolytes. There was no patient involvement and no adverse consequences associated with the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2016-00111 |
| MDR Report Key | 5398272 |
| Report Source | USER FACILITY |
| Date Received | 2016-01-29 |
| Date of Report | 2013-05-06 |
| Date of Event | 2013-05-06 |
| Date Mfgr Received | 2013-05-06 |
| Device Manufacturer Date | 2011-01-27 |
| Date Added to Maude | 2016-01-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CASEY METZGER |
| 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 | BATTERY |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2016-01-29 |
| Returned To Mfg | 2013-05-31 |
| Catalog Number | 4115000000 |
| Lot Number | 11027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-01-29 |