PROMARK ENDO MOTOR
Received Mar 19, 2026 · Event occurred Mar 17, 2026
Report 2320721-2026-00025 · MDR key 24637468
Device
Generic name
Handpiece, Direct Drive, Ac-powered
Manufacturer
Tulsa Dental Products LlcCatalog number
PMKEM1
Lot number
EMT20231027-082
Product problems
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A PROMARK ENDO MOTOR IS NOT RUNNING CORRECTLY, SPEED OF DEVICE IS NOT NORMAL. NO INJURY.
Additional Manufacturer Narrative
THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION HAS CAUSED FILE SEPARATION. SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.