MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for STORZ ICG LIGHT SOURCE 201337 20 manufactured by Karl Storz Imaging, Inc..
[118744439]
Pt sustained 5mm skin burn from light cord that was connected to storz icg light source which automatically defaults to 100%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079463 |
| MDR Report Key | 7826519 |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-26 |
| Date of Event | 2018-06-25 |
| Date Added to Maude | 2018-08-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | STORZ ICG LIGHT SOURCE |
| Generic Name | LIGHT SOURCE SYSTEM, DIAGNOSTIC ENDOSCOPIC |
| Product Code | OAY |
| Date Received | 2018-08-28 |
| Model Number | 201337 20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ IMAGING, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-28 |