MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-27 for VOCAL FOLD LIGHT CARRIER UMG 105LCN manufactured by Endocraft, Llc.
[18618498]
Pt having a microsurgical laryngoscopy with a stage excision of left vocal fold papilloma. A light source with the light source carrier was being used. Light source setting was at 100%. During case the pt's right upper lip was noted to be swollen with exudates. Light source and the light source carrier in the laryngoscope were removed and lip examined. A first-second degree burn was present on the right upper lip not affecting the vermillion border. Immediately ice was applied followed by topical bacitracin ointment. At end of procedure pt was transferred to the post anesthesia care unit in satisfactory condition. Pt discharged with instructions to continue ice, apply bacitracin and to see plastic surgeon.
Patient Sequence No: 1, Text Type: D, B5
[18698033]
A medwatch was recently filed by the (b) (6) hospital for an event in which a light carrier was responsible for a first-second degree burn to the skin on a pt's lip but not involving the vermillion border. The light carrier was returned to endocraft for evaluation on (b) (6) 2008, and the light cannula was clearly damaged in a way suggesting misuse, as the light carrier was severely bent (almost folded in half, with approx 70% of the fiber optics destroyed. A photograph of the returned light carrier is provided along with an unused light carrier and is attached to this mdr. In addition to the damaged light source, endocraft concluded that the clinician misused the device and did not follow common practice or the specific instructions for use accompanying the universal modular glottiscope. Those instructions explicitly delineate that the light carrier should not be in contact with pts' skin and that moist gauze should be placed between the light carrier and the pt's skin, which precludes the type of injury sustained in this report. If the instructions had been adhered to, the burning of the pt's lip would not have occurred. Also, the condition and bending of the light carrier allowed for the skin contact and suggested further misuse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225968-2008-00001 |
| MDR Report Key | 1213884 |
| Report Source | 05 |
| Date Received | 2008-10-27 |
| Date of Report | 2008-10-13 |
| Date of Event | 2008-07-28 |
| Date Mfgr Received | 2008-08-13 |
| Date Added to Maude | 2010-05-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENNIS DEVONA |
| Manufacturer Street | 25 NEW CHARDON STREET PO BOX 8666 |
| Manufacturer City | BOSTON MA 02114 |
| Manufacturer Country | US |
| Manufacturer Postal | 02114 |
| Manufacturer Phone | 4014547267 |
| Manufacturer G1 | ENDOCRAFT, LLC |
| Manufacturer Street | 3 CATALPA RD. |
| Manufacturer City | PROVIDENCE RI 02906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOCAL FOLD LIGHT CARRIER |
| Generic Name | LIGHT CARRIER |
| Product Code | KAA |
| Date Received | 2008-10-27 |
| Model Number | UMG 105LCN |
| Catalog Number | UMG 105LCN |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOCRAFT, LLC |
| Manufacturer Address | PROVIDENCE RI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-27 |