MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-21 for SKYTRON ST23 manufactured by Ddk.
[4984424]
During a thoracotomy a surgical light was brought into the field and the lens opened. Reflective material from the lens was able to enter the surgical site. It is suspected that some particles did land inside the pt. The surgeon also noted what seemed like dust in his eyes following the incident. Before closing the case skytron informed the surgeon that the materials making up the reflective material was sio and tio (silicon monoxide and titanium monoxide respectively). The surgeon proceeded with the case and closed the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2014-00014 |
| MDR Report Key | 4210249 |
| Date Received | 2014-10-21 |
| Date of Report | 2014-10-16 |
| Date of Event | 2014-01-03 |
| Date Facility Aware | 2014-10-03 |
| Report Date | 2014-10-16 |
| Date Reported to FDA | 2014-10-17 |
| Date Reported to Mfgr | 2014-10-17 |
| Date Added to Maude | 2014-10-30 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 5000 36TH ST., S.E. |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal | 49512 |
| Manufacturer G1 | SKYTRON, DIV. THE KMW GROUP, INC. |
| Manufacturer Street | 5000 36TH ST., S.E. |
| Manufacturer City | GRAND RAPIDS MI 49512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49512 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL LIGHT |
| Product Code | BWN |
| Date Received | 2014-10-21 |
| Model Number | ST23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DDK |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-21 |