MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-09 for FLEXIBLE INTUBATION VIDEO ENDOSCOPE 111302BDX manufactured by Karl Storz.
[25884377]
The karl storz flexible intubation video endoscope (part #11302 bdx) has a channel that requires cleaning. According to aami st91 pre-cleaning should begin at the point of use. The ifu for the karl storz product #11302bdx does not include point of use cleaning for the channel, it only discusses cleaning the exterior of the scope. Not having the pre-cleaning step of flushing fluids through the channel can result in the formation of bio-film.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056160 |
| MDR Report Key | 5077773 |
| Date Received | 2015-09-09 |
| Date of Report | 2015-09-09 |
| Date Added to Maude | 2015-09-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | FLEXIBLE INTUBATION VIDEO ENDOSCOPE |
| Generic Name | FLEXIBLE ENDOSCOPE |
| Product Code | GCQ |
| Date Received | 2015-09-09 |
| Model Number | 111302BDX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-09 |