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 LIGHTMAT ULTRA-THIN FLEXIBLE SURGICAL ILLUMINATOR UA2550 manufactured by Lumitex.
[906686]
The lightmat ultra-thin flexible surgical illuminator was used for visual clarity when working in the breast pockets of a patient undergoing a double mastectomy. When the drapes were pulled back for repositioning, the patient was noted to have three small burns. The hospital reported that the burns were a result of the lightmat ultra-thin flexible surgical illuminator.
Patient Sequence No: 1, Text Type: D, B5
[8078649]
The seriousness of the injury is minor, described by the hospital as 3 small burns, despite several attempts by lumitex md, inc. To ascertain other details, we could not learn other details about the injuries. The hospital investigation determined that the hospital plugged the light source into a light source cable that did not meet specifications. A 5mm light source cable was used instead of the specified 4mm cable. Use of a cable larger in diameter than 4mm can result in overheating. The potential for patient injury resulting from overheating is documented in the lightmat surgical illuminator labeling. The instructions for use contain a warning stating "do not use light sources rated higher than 300 watts, or cables with fiber optic bundles of more than 4mm diameter. Use of higher watt sources or larger diameter cables could result in overheating, causing product failure and patient injury. " in this case, the instructions for use were not followed. In response to this event, the local sales representative for lumitex md, provided re-training to the hospital staff on june 6, on the use of the lightmat product. Also, the hospital suggested that lumitex re-evaluate the cable design to prevent alternate cable compatibility. Many customers prefer a standard cable, as designed, so they can use existing hospital cables and not require custom purchases. Because the heating issue is covered in the ifu, and because we believe this is an isolated incident, lumitex will maintain the current design.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1528108-2008-00001 |
| MDR Report Key | 1073982 |
| Report Source | 05 |
| Date Received | 2008-07-03 |
| Date of Report | 2008-07-04 |
| Date of Event | 2008-04-28 |
| Date Mfgr Received | 2008-06-04 |
| Date Added to Maude | 2010-04-10 |
| 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 | THOMAS BLAICH, MANAGER |
| Manufacturer Street | 8443 DOW CIRCLE |
| Manufacturer City | STRONGSVILLE OH 44136 |
| Manufacturer Country | US |
| Manufacturer Postal | 44136 |
| Manufacturer Phone | 8009695483 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTMAT ULTRA-THIN FLEXIBLE SURGICAL ILLUMINATOR |
| Generic Name | LIGHTMAT SURGICAL ILLUMINATOR |
| Product Code | HJN |
| Date Received | 2008-07-03 |
| Model Number | UA2550 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMITEX |
| Manufacturer Address | STRONGSVILLE OH 44136 US 44136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-03 |