MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-03 for SKYTRON ST2323 manufactured by Dkk.
[25319024]
During a case, the diffuser and lens from a stellar surgical light fell open and debris fell into the surgical field. None of the debris fell into the patient and no injuries were reported. The bulbs for the lights have been changed by the operation room staff. When the light was evaluated, skytron's service tech found that the screw that holds the diffuser/filter assembly in the light was not secure. When it was bumped during surgery, the diffuser/filter assembly opened and debris inside the light fell. Skytron service tech replaced the diffuser/filter assembly and secured it properly. The other diffuser/filter assemblies were checked and secured as needed. The facility has six other operation room with stellar lights. These were checked and the issue was not found in any of the other lights. The facility has moved the responsibility of changing the bulbs to their biomed department to ensure this is done correctly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2015-00035 |
| MDR Report Key | 5065168 |
| Date Received | 2015-09-03 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-07-15 |
| Date Facility Aware | 2015-07-31 |
| Report Date | 2015-09-02 |
| Date Reported to FDA | 2015-09-02 |
| Date Reported to Mfgr | 2015-09-03 |
| Date Added to Maude | 2015-09-09 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON |
| Generic Name | SURGICAL LIGHT |
| Product Code | EBA |
| Date Received | 2015-09-03 |
| Model Number | ST2323 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DKK |
| Manufacturer Address | TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-03 |