VDW.GOLD RECIPROC
Received Jul 27, 2026
Report 9611053-2026-01186 · MDR key 50000749
Device
Product problems
- Use of Device Problem
Patient
Unknown
- Insufficient Information
Narrative
Description of Event or Problem
It was reported that a VDW. Gold Reciprocal motor suddenly stopped during treatment. The patient outcome is unknown as of this report.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21CFR Part 803.The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.