MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2012-03-29 for MAST QUADRANT RETRACTOR SYSTEM 9560658 manufactured by Warsaw Orthopedic, Inc..
[2596217]
It was reported that "during an unknown procedure, the light source overheated, stopped working, and had a smoky smell. " no patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[9719115]
(b)(4). 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. A review of the device history records for this device did not reveal any non-conformances to specification or deviations in procedure which might contribute to the reported event.
Patient Sequence No: 1, Text Type: N, H10
[9817328]
Analysis of the returned device shows that no pre-existing defect has been identified on the returned item that can be responsible of the event. The instruction for use of the device states: "the recommended light source utilizes 100w light sources and 5mm fiber optic cables. Use of larger cables and/or higher wattage light sources may result in high temperatures on the metal connection to the light cable, which may result in injury to patient or staff and damage to product. Reduce intensity levels on high watt light sources/large light cables and take precautions to protect patient and staff from injury. " the overheating and the damage of the device as described in the event may come from the use of inappropriate cables and/or wattage light source.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2012-00376 |
| MDR Report Key | 2509239 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2012-03-29 |
| Date of Report | 2012-04-05 |
| Date Mfgr Received | 2012-04-05 |
| Device Manufacturer Date | 2011-06-03 |
| Date Added to Maude | 2012-06-18 |
| 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 | 3 |
| Event Location | 3 |
| 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 | MAST QUADRANT RETRACTOR SYSTEM |
| Generic Name | LIGHT, SURGICAL, CARRIER |
| Product Code | FSZ |
| Date Received | 2012-03-29 |
| Returned To Mfg | 2012-03-16 |
| Model Number | 9560658 |
| Catalog Number | 9560658 |
| Lot Number | 0163330W |
| 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 ORTHOPEDIC, INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-29 |