MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-18 for N/A UNKNOWN manufactured by Surgical Laser Technologies (slt).
[1402]
Dr. Was using filter endoscopic 2. 2 mm tip with slt laser. When removing tip it was discovered to be burned off. Filter was changed immediately and tip recoveredinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device discarded, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2467 |
| MDR Report Key | 2467 |
| Date Received | 1993-01-18 |
| Date of Event | 1992-11-23 |
| Date Facility Aware | 1992-11-23 |
| Date Reported to Mfgr | 1993-01-04 |
| Date Added to Maude | 1993-03-09 |
| 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 |
| 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 | N/A |
| Generic Name | ENDOSCOPE 2.2 FIBER FOR SLT LASER |
| Product Code | GDB |
| Date Received | 1993-01-18 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2292 |
| Manufacturer | SURGICAL LASER TECHNOLOGIES (SLT) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-01-18 |