MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-27 for CO2 LASER 1041 manufactured by Sharplan.
[142262]
The surgeon was using a shaplan laser to perform an adenodectomy. The sheath that the waveguide went through became very hot when it came into contact with the pt's lip it burned it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 234723 |
| MDR Report Key | 234723 |
| Date Received | 1999-07-27 |
| Date of Report | 1999-07-27 |
| Date of Event | 1999-07-22 |
| Date Facility Aware | 1999-07-22 |
| Report Date | 1999-07-27 |
| Date Reported to FDA | 1999-07-27 |
| Date Reported to Mfgr | 1999-07-22 |
| Date Added to Maude | 1999-08-09 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | CO2 LASER |
| Generic Name | LASER |
| Product Code | EWG |
| Date Received | 1999-07-27 |
| Model Number | 1041 |
| Catalog Number | 2 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 11 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 227474 |
| Manufacturer | SHARPLAN |
| Manufacturer Address | 1 PEARL COURT ALLENDALE NJ 07401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-07-27 |