MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-16 for CONTACT LASER SCALPEL N/A FLS300-EH4-US manufactured by Hgm Medical Laser Systems Inc..
[2539]
Contact lasers scalpel (lot #35292f300a-12) set @ 8 watts and fired inside nose on nasal polyps. A blue-green light was visible at the tip when the laser was fired. Physician had fired the laser several times at which time the fiber failed. Patient sustained a 6x4mm second degree burn on the right nasal sill. Inspection of the fiber showed that the metal sheath had been blackened from the bend distal for 7mm. The degree of charring was worse on the concave (underside) halfdevice not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: telemetry failure. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: inserviced by other facility staff. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6302 |
| MDR Report Key | 6302 |
| Date Received | 1993-08-16 |
| Date of Report | 1993-07-21 |
| Date of Event | 1993-07-01 |
| Date Facility Aware | 1993-07-01 |
| Report Date | 1993-07-21 |
| Date Reported to FDA | 1993-07-21 |
| Date Reported to Mfgr | 1993-07-02 |
| Date Added to Maude | 1993-08-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTACT LASER SCALPEL |
| Generic Name | N/A |
| Product Code | LQJ |
| Date Received | 1993-08-16 |
| Model Number | N/A |
| Catalog Number | FLS300-EH4-US |
| Lot Number | 35292F300A-12 |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5991 |
| Manufacturer | HGM MEDICAL LASER SYSTEMS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-08-16 |