MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-19 for DYONICS ABI 11 * manufactured by Smith & Nephew Dyonics.
[203282]
Pt underwent direct laryngoscopy with vocal cord biopsy due to endolaryngeal lesions. The lesion was photo documented by passing the 4mm nasal telescope through the dido laryngoscope. Light cord connection to scope was "hot". At conclusion of the procedure, the room lights were brightened and drapes were removed, it became evident that the pt sustained a partial thickness burn to the nasal tip skin. No other injury was identified. Silvadene cream was thereafter applied to the area. Findings and management of this complication was fully discussed with pt and pt's spouse. Pt will be followed up by md in office. Md was new to this hosp and was unaware that hosp was only "hot" light sources in the operating room. This light source was compared to a second like light source and was felt to be warmer than usual at connector to scope. Biomedical engineer examined device and found no defect or problem with equipment. Dyonics rep contacted and, after signing a release form, took the equipment for evaluation on 01/08/2001, observed no problems on initial evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 313183 |
| MDR Report Key | 313183 |
| Date Received | 2001-01-19 |
| Date of Report | 2001-01-18 |
| Date of Event | 2001-01-05 |
| Date Facility Aware | 2001-01-05 |
| Report Date | 2001-01-18 |
| Date Reported to FDA | 2001-01-18 |
| Date Reported to Mfgr | 2001-01-18 |
| Date Added to Maude | 2001-01-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYONICS |
| Generic Name | FO LIGHT SOURCE |
| Product Code | FCR |
| Date Received | 2001-01-19 |
| Model Number | ABI 11 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4.5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 302921 |
| Manufacturer | SMITH & NEPHEW DYONICS |
| Manufacturer Address | 175 ANDOVER STREET DANVERS MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-01-19 |