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 2013-06-11 for QUADRANT ILLUMINATION SYSTEM 9560658 manufactured by Warsaw Orthopedics.
[3485087]
It was reported that a patient underwent an unknown procedure. During the procedure, "the illumination system cable melted near the acmi system. The tubing burned through the sterile draping of the patient and caused a blister to the left side of the patient approximately the size of a 20 cent piece. The nurse applied comfeel dressing to the blistered site immediately after surgery was completed. " no further details are known at this time.
Patient Sequence No: 1, Text Type: D, B5
[10816834]
(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
[18407306]
Analysis of the returned device shows that 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. A query of the complaint database as of (b)(4) 2013 did not identify any other complaint with respect to this pn/lot# combination. The above observations are consistent with exceeding power limits of the instrument during usage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2013-02155 |
| MDR Report Key | 3162678 |
| Report Source | 01,05,07 |
| Date Received | 2013-06-11 |
| Date of Report | 2013-07-31 |
| Date of Event | 2013-06-05 |
| Date Mfgr Received | 2013-07-31 |
| Device Manufacturer Date | 2012-10-05 |
| Date Added to Maude | 2013-06-11 |
| 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 | QUADRANT ILLUMINATION SYSTEM |
| Generic Name | TAPE, MEASURING, RULERS AND CALIPERS |
| Product Code | FTY |
| Date Received | 2013-06-11 |
| Returned To Mfg | 2013-06-19 |
| Catalog Number | 9560658 |
| Lot Number | 0236048W |
| Device Expiration Date | 2017-10-18 |
| 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 | 2013-06-11 |