inforMED
MalfunctionNLR

BOSTON SCIENTIFIC TRUETOME 44-30MM CUT WIRE 4.4F X 30MM

Received Mar 18, 2025 · Event occurred Mar 12, 2025

Report MW5167766 · MDR key 21633966

Device

Generic name

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Model number

M00584180

Lot number

34902720

Patient

60 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT UNDERGOING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY). EQUIPMENT MALFUNCTION INTRAOPERATIVELY. EQUIPMENT WAS SWITCHED OUT. NO HARM TO THE PATIENT. TRUETOME 44 30MM CUTE WIRE DID NOT TRIGGER TO CUT DURING PROCEDURE WHEN HOOKED UP TO ERBE MACHINE. NEW ERBE MACHINE WAS BROUGHT INTO PROCEDURE ROOM, TOME WAS PLUGGED IN AND STILL DID NOT FIRE. BOSTON SCIENTIFIC REP STATED IT COULD HAVE POSSIBLY BEEN THE TOME WE WERE USING, SO WE IMMEDIATELY REMOVED FROM PATIENT, SWAPPED IT OUT FOR A NEW TOME AND IT SUCCESSFULLY FIRED. BOSTON SCIENTIFIC TRUETOME 44-30MM CUT WIRE 4.4F X 30MM, GTIN: (B)(4), REF: M00584180, LOT: 34902720.