MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-07-03 for MAST QUADRANT RETRACTOR SYSTEM 9560658 manufactured by Warsaw Orthopedic Inc..
[889899]
It was reported that during surgery while using the illumination system, the cable melted, creating smoke/heat and would not function properly. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[7891053]
The light cable was returned to medtronic for evaluation. A visual examination of the cable confirms high temps present at the light source attachment end. This suggests the use of a machine with greater than the 100w instructed on the packaging. Package labeling indicates that the recommended light source utilizes 100w light sources and 5mm 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2008-00308 |
| MDR Report Key | 1070061 |
| Report Source | 05 |
| Date Received | 2008-07-03 |
| Date of Report | 2008-06-06 |
| Date of Event | 2008-05-23 |
| Date Mfgr Received | 2008-06-06 |
| Device Manufacturer Date | 2008-03-20 |
| Date Added to Maude | 2008-10-01 |
| 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 | CHAD ASHTON |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | WARSAW ORTHOPEDIC INC |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46852 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46852 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAST QUADRANT RETRACTOR SYSTEM |
| Generic Name | ILLUMINATION SYSTEM |
| Product Code | FSZ |
| Date Received | 2008-07-03 |
| Returned To Mfg | 2008-06-09 |
| Model Number | NA |
| Catalog Number | 9560658 |
| Lot Number | W08B1264 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1208611 |
| Manufacturer | WARSAW ORTHOPEDIC INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-03 |