MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-09 for COHERENT SLIMLINE 550/SN SLIM LINE 550/SN PART NU #0624-149-55 manufactured by Coherent.
[63898]
During bronchus tumor ablation procedure, the surgeon noted sparks on the monitor and immediately removed scope. Pt was immediately extubated, re-intubated. New bronchoscopy was inserted and showed possible "bronchial thermal injury. " equipment was examined - showing et. Tube scorched, laser fiber broken, burnt, and split. Large area burned in bronchoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 97523 |
| MDR Report Key | 97523 |
| Date Received | 1997-06-09 |
| Date of Report | 1997-06-03 |
| Date of Event | 1997-05-29 |
| Date Facility Aware | 1997-05-29 |
| Report Date | 1997-06-03 |
| Date Reported to FDA | 1997-06-05 |
| Date Reported to Mfgr | 1997-06-05 |
| Date Added to Maude | 1997-06-13 |
| 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 | 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 | COHERENT SLIMLINE 550/SN |
| Generic Name | LASER FIBER |
| Product Code | LLO |
| Date Received | 1997-06-09 |
| Model Number | SLIM LINE 550/SN |
| Catalog Number | PART NU #0624-149-55 |
| Lot Number | 101596 |
| ID Number | * |
| Device Expiration Date | 2001-10-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 96234 |
| Manufacturer | COHERENT |
| Manufacturer Address | 3270 WEST BAY SHORE RD PALO ALTO CA 94303 US |
| Baseline Brand Name | VERSATOME SLIMLINE (550) |
| Baseline Generic Name | FIBER |
| Baseline Model No | NA |
| Baseline Catalog No | * |
| Baseline ID | K960032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1997-06-09 |