PROMARK ENDO MOTOR
Received Mar 31, 2026 · Event occurred Mar 25, 2026
Report 2320721-2026-00031 · MDR key 24744868
Device
Generic name
Handpiece, Direct Drive, Ac-powered
Manufacturer
Tulsa Dental Products LlcCatalog number
PMKEM1
Product problems
- Mechanical Problem
- Device Handling Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A PROMARK ENDO MOTOR STOPS DURING USE, DEVICE RUNNING ERRATIC. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
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.