VDW.SILVER RECIPROC
Received May 4, 2026
Report 9611053-2026-00131 · MDR key 25070207
Device
Product problems
- Mechanical Problem
- Device Handling Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS KIND OF 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 21 CFR 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.
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A VDW.SILVER RECIPROC STOPS DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR .FURTHER INFORMATION REQUESTED.