MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for LED POWER 20161420-1 20161420 manufactured by Karl Storz Gmbh & Co. Kg.
[72544382]
Patient Sequence No: 1, Text Type: N, H10
[72544383]
During the course of a meatotomy, the light source device was assumed to be on standby mode by the surgical staff. It was not in use by the surgeon at the time. When the device was examined following the procedure, it was noted that the design of the device is not user friendly and confusing. To place the device on standby, one has to press a power button next to the circular outlet for the fiberoptic cord and this button will light up. It makes it appear that the device is on and ready for use, when it is actually on standby mode. When you turn this power button off (take the device off of standby mode), the circular outlet for the fiberoptic cord and the display (indicating the intensity) lights up. Also, when the device is turned completely off and then back on, it defaults to the previous setting, whether it is at 0 or 100.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6484960 |
| MDR Report Key | 6484960 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-07 |
| Date of Event | 2017-02-03 |
| Report Date | 2017-03-31 |
| Date Reported to FDA | 2017-03-31 |
| Date Reported to Mfgr | 2017-03-31 |
| Date Added to Maude | 2017-04-12 |
| 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 |
| 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 | LED POWER |
| Generic Name | LED LIGHT SOURCE |
| Product Code | NTN |
| Date Received | 2017-04-12 |
| Model Number | 20161420-1 |
| Catalog Number | 20161420 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | 2151 E GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-12 |