inforMED
MalfunctionGXD

STRYKER GROUNDING PAD

Received Jun 1, 2026 · Event occurred May 28, 2026

Report MW5188746 · MDR key 25348105

Device

Generic name

Generator, Lesion, Radiofrequency

Catalog number

0406-650-210

Lot number

202709LX

Product problems

  • Connection Problem
  • Therapeutic or Diagnostic Output Failure

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

AT THE PAIN CLINIC, ON (B)(6) 2026, WE HAD A PROCEDURE. CONNECTED GROUNDING PAD (PRODUCT # 0406-650-210) TO CABLE, NOT REGISTERED. CHANGE PAD, SAME RESULT, CHANGED CABLE W/ SAME RESULT. TRIED DIFFERENT MACHINE W/SAME RESULT. AT THIS TIME, LOOKED FOR DIFFERENT PAD- HAD SOME OLD STOCK OF 0406-650-205, CONNECTED PAD, WORKED AS INTENDED. PULLED ALL STOCK WITH SAME LOT NUMBER 202709LX. PROCEED TO DO PROCEDURE WITH OLD PAD, WORKED EFFECTIVELY. NO HARM TO PATIENT DONE. IN THE EVENT WE DIDN'T HAVE SOME OF THE OLD STOCK, WE WOULD'VE HAD TO CANCEL 3-4 PATIENTS TODAY, AND UNTIL FURTHER NOTICE. ALL PHYSICIANS, CNOIC, NCOIC WERE NOTIFIED. (B)(4) WAS INITIATED BY (B)(6) CNOIC. I BELIEVE THIS ITEM IS DEFICIENT. THIS WAS DISCOVERED TODAY. OUR MAIN SUPPLIER I UNDERSTAND IS (B)(4), AND THERE ARE NO SUBSTITUTIONS AVAILABLE THROUGH GOVERNMENT CONTRACTED SUPPLIERS. STRYKER IS THE RF GENERATOR MANUFACTURER, AND SUPPLIES (B)(4) WITH THIS PRODUCT. THE PREVIOUS VERSION OF THIS SAME PRODUCT PROVED TO BE STABLE. HOWEVER, THIS NEW VERSION OF THEIR PRODUCT, IN ADDITION TO BEING ALMOST 4X MORE EXPENSIVE, SEEMS NOT AS EFFECTIVE AS THE PREVIOUS VERSION. AT LEAST 10 PC TESTED. 85 ON HAND TO TURN IN. WO#: (B)(4) INITIATED WITH MED MAINT. PT: 4582. DEVICE: 3023, 2900. REFERENCE REPORT:  MW5188744, MW5188745, MW5188747, MW5188748, MW5188749, MW5188750, MW5188751, MW5188752, MW5188753.