MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-18 for MAST QUADRANT RETRACTOR SYSTEM 9560658 manufactured by Warsaw Orthopedics.
[3995439]
It was reported that during the surgery, the doctor noted that illumination system was not working effectively while performing the disc preparation. Sometime had passed and the orthopedic resident grabbed the threaded interface of the illumination device and light source cable. It was so hot to the touch that it nearly burned through his surgical glove. He was not harmed in any way. The doctor had noticed under close inspection that the metal threaded interface that connects to the black plastic illumination cable had melted. He immediately requested that the light source be shut off. The metal interface eventually cooled down. There was no reported negative effect to the success of the procedure and the patient was not harmed in any way.
Patient Sequence No: 1, Text Type: D, B5
[11463014]
(b)(4): the device was not returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[11600955]
Additional information: 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.? Visual review of the instrument identified illuminator light source fitting that appeared to be exposed to high heat, as evidence by discoloration and melting of the optical fibers at the light source fitting. The above observations are consistent with exceeding power limits of the instrument during usage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2013-05115 |
| MDR Report Key | 3525933 |
| Report Source | 05,07 |
| Date Received | 2013-12-18 |
| Date of Report | 2013-11-25 |
| Date of Event | 2013-11-25 |
| Date Mfgr Received | 2014-04-01 |
| Device Manufacturer Date | 2013-06-11 |
| Date Added to Maude | 2014-03-20 |
| 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 | 2013-12-18 |
| Returned To Mfg | 2013-12-10 |
| Model Number | NA |
| Catalog Number | 9560658 |
| Lot Number | 0268372W |
| Device Expiration Date | 2018-06-14 |
| 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 | 2013-12-18 |