MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-20 for POWER LED 175 LIGHT SOURCE 20161401-1 manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[58019173]
We have relevant warnings in the ifu on the light source/20161401-1 and the flexible scope/ 11272vn that was attached to the light source: light source: warning: the light port and the housing may be hot. Warning: risk of burns: the light outlet may heat up to over 41? C. Flexible scope: warning: high energy light radiated through flexible video-urethro-cystoscopes may give rise to high temperatures in front of the light outlet, at the end faces of the light guide and at the tip of the flexible video-urethro-cystoscope. Prolonged direct contact of light-emitting surfaces on tissue can lead to burns, this must therefore be avoided at all costs. Warning: even after the proximal connector is removed from the light source, surfaces will remain hot for a period of time (risk of user being burnt). Device not returned yet.
Patient Sequence No: 1, Text Type: N, H10
[58019174]
Allegedly, after the procedure was completed, the nurse removed a flexible scope that was connected to the light source and was placing it in the sterilization tray when the proximal cable tip of the flexible scope made contact with the inside of her forearm causing a burn. The burn blistered and she treated with ointment; burn has healed.
Patient Sequence No: 1, Text Type: D, B5
[81024607]
Unable to duplicate customer complaint. During the evaluation, unit is working properly; it passes all the functional, safety tests.
Patient Sequence No: 1, Text Type: N, H10
[81024608]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2016-00159 |
| MDR Report Key | 6045893 |
| Date Received | 2016-10-20 |
| Date of Report | 2016-09-20 |
| Date of Event | 2016-09-20 |
| Date Mfgr Received | 2016-09-20 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2016-10-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Street | MITTLESTRASSE 8, 78503 |
| Manufacturer City | TUTTLINGEN, GERMANY, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POWER LED 175 LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | NTN |
| Date Received | 2016-10-20 |
| Returned To Mfg | 2016-11-01 |
| Model Number | 20161401-1 |
| Catalog Number | 20161401-1 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8, 78503 TUTTLINGEN, GERMANY, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-20 |