MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for C-MAC VIDEO LARYNGOSCOPE manufactured by Karl Storz Endoscopy-america, Inc..
[42306967]
Patient Sequence No: 1, Text Type: N, H10
[42306968]
This has been an ongoing issue with the video laryngoscope. Using the mac #3, the video cable kinks when going into the plastic cover and does not work well. If the mac #4 is used, it is completely obstructed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5567219 |
| MDR Report Key | 5567219 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-04-01 |
| Date of Event | 2015-07-20 |
| Report Date | 2016-04-01 |
| Date Reported to FDA | 2016-04-01 |
| Date Reported to Mfgr | 2016-04-01 |
| Date Added to Maude | 2016-04-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| 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 | 3 |
| Brand Name | C-MAC VIDEO LARYNGOSCOPE |
| Generic Name | LARYNGOSCOPE, NON-RIGID |
| Product Code | CAL |
| Date Received | 2016-04-11 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 | 2016-04-11 |