MalfunctionGXD

MULTIGEN 2

Received Jul 9, 2026 · Event occurred Jun 10, 2026

Report 25762039 · MDR key 25762039

Device

Generic name

Generator, Lesion, Radiofrequency

Manufacturer

Stryker Corp

Model number

8400-000-000

Catalog number

8400-000-000

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT WAS BROUGHT IN FOR CERVICAL RFA [RADIOFREQUENCY ABLATION] PROCEDURE. RN PULLED MACHINE NEAR BED AND PLUG GOT CAUGHT AND MACHINE WAS UNPLUGGED. PLUGGED MACHINE BACK IN AND TURNED ON. MACHINE TURNED ON AND SHOWED FLASHING ERROR MESSAGE, WOULD NOT RETURN TO REGULAR SCREEN. ATTEMPTED TO REBOOT AND CHANGE PLUG TO DIFFERENT OUTLET. RN ASKED COORDINATOR TO CONTACT STRYKER REP FOR ASSISTANCE. REP UNABLE TO TROUBLESHOOT OVER PHONE, NEEDED TO COME AND BRING A LOANER MACHINE. MD DECIDED TO REMOVE THE CERVICAL NEEDLES FROM PATIENT AND CANCEL THE PROCEDURE. SEDATION RN PLACED DRESSING ON THE PATIENT'S NEEDLE SITES AND BROUGHT PATIENT TO PACU [POST ANESTHESIA RECOVERY UNIT].