MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-06 for 300 WATT XENON LIGHT SOURCE 201331-20-1 manufactured by Karl Storz Endovision.
[49644170]
The light source will not be returned by the hospital. The biomed at the hospital provided a report along with pictures and sent to us. Based on the report and pictures, the manufacturer provides a possible evaluation: we reviewed the evaluation report from the biomedical engineer from credit valley. Kse assessment below: problem: a short occurred between the negative power line for the lamp assembly and the high voltage power board. Kse assessment: it appears from the picture that the insulation on the negative high voltage lead came in contact with the lamp power supply plate. The likely cause could be improper cable routing, or damaged/missing cable tie. This cable tie is used to maintain the position of the negative high voltage lead. Unit is ten (10) years old. Shipped to customer in 11/2006. No history of service repair. We think it possible that this unit has been repaired and maintained by 3rd party. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[49644171]
Allegedly, during a cystolitholapaxy/turp, the light source started smoking. The surgeon had to abort the case and clear the room. There was no report of injury to the patient. They used a powder type fire extinguisher to spray unit down. Unit was removed from service and brought down to hospital's biomedical department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221826-2016-00100 |
| MDR Report Key | 5774219 |
| Date Received | 2016-07-06 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-05-04 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2007-03-07 |
| Date Added to Maude | 2016-07-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 ENDOVISION |
| Manufacturer Street | 91 CARPENTER HILL ROAD |
| Manufacturer City | CHARLTON MA 01507 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 300 WATT XENON LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2016-07-06 |
| Model Number | 201331-20-1 |
| Catalog Number | 201331-20-1 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOVISION |
| Manufacturer Address | 91 CARPENTER HILL ROAD CHARLTON MA 01507 US 01507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-06 |