MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-02-17 for METRX SYSTEM 9560702 manufactured by Warsaw Orthopedics.
[3330119]
It was reported that the light source caught on fire during a microdiscectomy. No patient complications were reported. No further details are known at this time.
Patient Sequence No: 1, Text Type: D, B5
[10459871]
(b)(6). (b)(4). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[10568090]
The device has been returned to the manufacturer for evaluation. Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete.
Patient Sequence No: 1, Text Type: N, H10
[20421251]
Analysis of the returned device shows that visual and optical examination of the returned instrument identified appearance of plastic optical fiber strands melted, consistent with exceeding power limits during usage, per the caution label on the outside of the instrument packaging. The above observations are consistent with inappropriate usage of the instrument.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2013-00526 |
| MDR Report Key | 2966043 |
| Report Source | 01,05,07 |
| Date Received | 2013-02-17 |
| Date of Report | 2013-07-24 |
| Date of Event | 2013-02-07 |
| Date Mfgr Received | 2013-07-24 |
| Device Manufacturer Date | 2012-06-22 |
| Date Added to Maude | 2013-04-18 |
| 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 | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METRX SYSTEM |
| Generic Name | LIGHT, SURGICAL, CARRIER |
| Product Code | FSZ |
| Date Received | 2013-02-17 |
| Returned To Mfg | 2013-07-24 |
| Catalog Number | 9560702 |
| Lot Number | 0222865W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-17 |