MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-21 for ARTHREX VIDEO SYSTEM manufactured by Arthrex.
[58403407]
Patient underwent shoulder surgery. Arthrex camera and light box momentarily malfunctioned. Approximately 75 seconds after case start, video source and light source were lost. Arthrex representative was in room and unable to regain light source. Video was regained and headlight box was used for light source. Printer then printed previous case overtop of current case on same paper with both patients information overlaying each other. There was no injury to the patient. Operating room leadership referred the situation to the arthrex representative for follow-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065582 |
| MDR Report Key | 6053722 |
| Date Received | 2016-10-21 |
| Date of Report | 2016-10-21 |
| Date of Event | 2016-09-23 |
| Date Added to Maude | 2016-10-25 |
| 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 |
| 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 | 0 |
| Brand Name | ARTHREX VIDEO SYSTEM |
| Generic Name | ARTHREX VIDEO SYSTEM |
| Product Code | FWL |
| Date Received | 2016-10-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-21 |