MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for XENON LIGHT SOURCE/FLASH 20133120 manufactured by Karl Storz Endoscopy-america, Inc..
[137122833]
Complaint of device emitted smoke confirmed based on visual observations + odor present. Device turned on but would not illuminate bulb. Found internal fuse f1 open on xenon lamp power supply board. Observation of component capacitor c4 on xenon lamp power supply indicates a failure/thermal event took place. Component is discolored and plastic is disfigured. Device was in use at time of event in operating room. A code red? Fire/smoke response by staff and emergency services took place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8369613 |
| MDR Report Key | 8369613 |
| Date Received | 2019-02-26 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-10-03 |
| Report Date | 2019-02-12 |
| Date Reported to FDA | 2019-02-12 |
| Date Reported to Mfgr | 2019-02-26 |
| Date Added to Maude | 2019-02-26 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XENON LIGHT SOURCE/FLASH |
| Generic Name | LIGHT SOURCE, PHOTOGRAPHIC, FIBEROPTIC |
| Product Code | FCR |
| Date Received | 2019-02-26 |
| Model Number | 20133120 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-26 |