MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-07-21 for SKYTRON ST23 manufactured by Dai-ichi Shomei.
[6036231]
During a surgical procedure, hospital staff noted white plastic pieces floating down from the surgical light into the sterile field. No injuries were reported. The surgery was completed as scheduled. Upon investigation, facility's biomed noted that the end cap of the light was damaged and appeared to be chipped away from use and potential collision with other equipment. All surgical lights in the facility were inspected and other lights were found to be in a similar condition. Facility ordered replacement caps for and will replace them upon receipt. Facility is returning damaged caps to (b)(4) for further evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2015-00032 |
| MDR Report Key | 4947366 |
| Report Source | 99 |
| Date Received | 2015-07-21 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-07-13 |
| Date Facility Aware | 2015-07-14 |
| Report Date | 2015-07-21 |
| Date Reported to FDA | 2015-07-20 |
| Date Reported to Mfgr | 2015-07-21 |
| Date Added to Maude | 2015-07-29 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL LIGHT |
| Product Code | EBA |
| Date Received | 2015-07-21 |
| Model Number | ST23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAI-ICHI SHOMEI |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-21 |