MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-15 for SLT CLMD-30 30 WATT ND: YAG LASER SKU# FA5336 manufactured by Uhs.
[26242974]
During a surgical procedure, the yag laser was placed on standby function, which malfunctioned, leading to the laser becoming very hot, and a puddle of coolant was leaked onto the floor. No harm to the patient or staff. The laser did work properly during use prior to being placed on standby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056244 |
| MDR Report Key | 5088314 |
| Date Received | 2015-09-15 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-09-09 |
| Date Added to Maude | 2015-09-18 |
| 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 | 3 |
| Brand Name | SLT CLMD-30 30 WATT ND: YAG LASER |
| Generic Name | SLT CLMD-30 30 WATT ND: YAG LASER |
| Product Code | LLO |
| Date Received | 2015-09-15 |
| Catalog Number | SKU# FA5336 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UHS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-15 |