MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-21 for SKYTRON SURGICAL LIGHT MODEL ST2323 ST 2323 manufactured by Skytron.
[16015480]
Surgical operating room light lense cover broke and a particle fell into the abdomen of a pt during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033082 |
| MDR Report Key | 3489567 |
| Date Received | 2013-11-21 |
| Date of Report | 2013-11-20 |
| Date of Event | 2013-11-20 |
| Date Added to Maude | 2013-11-27 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYTRON SURGICAL LIGHT MODEL ST2323 |
| Generic Name | MODEL ST2323 SURGICAL LIGHT |
| Product Code | FQP |
| Date Received | 2013-11-21 |
| Model Number | ST 2323 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYTRON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2013-11-21 |