MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-03-19 for LUXTEC 88-9727 manufactured by Integra Luxtec, Inc..
[21589783]
User reported a pt burn while using a breast retractor with a fiber optic cable (light guide). The manufacturer of the breast retractor (customer - cardinal heath) recommends use of a 3. 5 mm cable to ensure the cable fits well to the retractor. Their customer chose to use a 5. 0 mm cable. When using an oversized cable light will escape from the retractor connection and cause the cable endtip to get hot. If the cable is then laid on the pt, there is a potential for the pt to be burned - cardinal health warns against this in their retractor ifu. Based on the description of the event provided by the user; add'l info gathered by our oem customer; and, the fact that our oem customer examined the cable and found no indication of damage, we believe the user laid the hot cable against the pt and a burn resulted. The cable performed properly, unfortunately someone chose to use an oversized cable and then laid the hot cable against the pt and this led to the burns reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221336-2008-00001 |
| MDR Report Key | 1015096 |
| Report Source | 99 |
| Date Received | 2008-03-19 |
| Date of Report | 2008-03-19 |
| Date of Event | 2008-02-05 |
| Date Mfgr Received | 2008-02-19 |
| Date Added to Maude | 2009-05-01 |
| 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 | RITA WADLEIGH |
| Manufacturer Street | 99 HARTWELL ST. |
| Manufacturer City | WEST BOYLSTON MA 01583 |
| Manufacturer Country | US |
| Manufacturer Postal | 01583 |
| Manufacturer Phone | 5088359700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUXTEC |
| Generic Name | LIGHT GUIDE OR CABLE |
| Product Code | EQH |
| Date Received | 2008-03-19 |
| Model Number | 88-9727 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LUXTEC, INC. |
| Manufacturer Address | 99 HARTWELL ST. WEST BOYLSTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-03-19 |