VDW.SILVER RECIPROC
Received Jan 12, 2026
Report 9611053-2026-00007 · MDR key 24035893
Device
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 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 STOPPED OFTEN DURING TREATMENT. NO INJURY OCCURRED. WE DO NOT KNOW EXACTLY HOW MANY PATIENT ARE AFFECTED BY THIS DEVICE MALFUNCTION, THEREFORE WE HAVE CREATED 2 CASES FOR THIS EVENT. THIS IS CASE 1 OF 2.