MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-22 for SLT-SURGICAL LASER TECHNOLOGIES * 1.8 BLUE LASER FIBER manufactured by Surgical Laser Technologies, Inc..
[93879]
Laser bronchoscopy procedure, 1. 8 fiber used per guidelines, surgeon requested round tip, nurse screwed tip on securely. When surgeon pulled fiber out of scope, the entire "screwed on" tip & a piece of the fiber remained in the bronchus. Surgeon was able to retrieve the tip & attachment from the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012708 |
| MDR Report Key | 140863 |
| Date Received | 1997-12-22 |
| Date of Report | 1997-12-22 |
| Date of Event | 1997-12-22 |
| Date Added to Maude | 1998-01-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLT-SURGICAL LASER TECHNOLOGIES |
| Generic Name | FIBER DELIVERY SYSTEM |
| Product Code | LLO |
| Date Received | 1997-12-22 |
| Model Number | * |
| Catalog Number | 1.8 BLUE LASER FIBER |
| Lot Number | 112009 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 137522 |
| Manufacturer | SURGICAL LASER TECHNOLOGIES, INC. |
| Manufacturer Address | 147 KEYSTONE DR. MONTGOMERYVILLE PA 18936 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-12-22 |