MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-13 for SLT FIBER DELIVERY SYSTEM 600 MICRON FIBER WITH 1.8MM OD SFE 1.8 manufactured by Surgical Laser Technology.
[3397]
During dr. 's case, the screw tip on the end of the handpiece fell off into the patient's lung. The dr. Attempted to retreive the tip with graspers but was unsuccessfuldevice labeled for single use. Patient medical status prior to event: fair condition. 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5667 |
| MDR Report Key | 5667 |
| Date Received | 1993-07-13 |
| Date of Report | 1993-06-22 |
| Date of Event | 1993-05-17 |
| Date Facility Aware | 1993-05-17 |
| Report Date | 1993-06-22 |
| Date Added to Maude | 1993-07-20 |
| 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 | SLT FIBER DELIVERY SYSTEM |
| Generic Name | FIBER FOR ENDOSCOPY |
| Product Code | GDB |
| Date Received | 1993-07-13 |
| Model Number | 600 MICRON FIBER WITH 1.8MM OD |
| Catalog Number | SFE 1.8 |
| Lot Number | 1202003 |
| ID Number | NONE |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 5366 |
| Manufacturer | SURGICAL LASER TECHNOLOGY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-07-13 |