MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-28 for KARL STORZ CAMERA 212020 manufactured by Karl Storz.
[74294529]
Patient for laparoscopic repair of a right inguinal hernia. During the procedure dark smoke was noted from the camera unit of the laparoscopy tower. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069483 |
| MDR Report Key | 6538101 |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-19 |
| Date of Event | 2016-12-23 |
| Date Added to Maude | 2017-05-02 |
| 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 | 3 |
| Reporter Occupation | UNKNOWN |
| 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 | KARL STORZ CAMERA |
| Generic Name | CAMERA |
| Product Code | FXM |
| Date Received | 2017-04-28 |
| Model Number | 212020 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 2151 E GRAND AVENUE SEGUNDO CA 902455017 US 902455017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-28 |