MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-05-28 for MAST QUADRANT RETRACTOR SYSTEM 9560658 manufactured by Warsaw Orthopedics.
[17950340]
It was reported that during surgery the surgeon was burned three times by the light source and then the light stopped functioning. Reportedly, the burns were not severe and did not melt the surgeon? S gloves or leave a mark on the skin, but it was more shocking and unexpected. The incident added time to the procedure as the surgeon had to regain composure each time. After the light stopped functioning there was no backup so the surgeon had to rely on his head lamp and overhead lights which wasn? T ideal. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
[18076015]
(b)(4): visual review of the instrument identified illuminator light source fitting that appeared to be exposed to high heat, as evidence by discoloration of the optical fibers at the fitting and melting of both the external sheath and internal optical fibers. The damage is consistent with exceeding power limits of the instrument during usage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-02654 |
| MDR Report Key | 3836157 |
| Report Source | 05,07 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-02-04 |
| Date of Event | 2014-02-03 |
| Date Mfgr Received | 2014-02-04 |
| Device Manufacturer Date | 2013-09-03 |
| Date Added to Maude | 2014-05-28 |
| 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 | 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 | 2014-05-28 |
| Returned To Mfg | 2014-03-24 |
| Model Number | NA |
| Catalog Number | 9560658 |
| Lot Number | 0274914W |
| Device Expiration Date | 2018-07-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Other | 2014-05-28 |