Fusion G48675Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002486751), received between Jul 1, 2016 and Apr 28, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME SPHINCTEROTOME. WHEN THE SPHINCTEROTOME EXITED DISTAL END OF THE ENDOSCOPE IT POINTED TO THE LEFT [INCORRECT CUTTING WIRE ORIENTATION]. WHEN THE DOCTOR ASKED FOR IT TO BE BOWED UP IT TURNED LEFT WHICH MADE CANNULATION ALMOST IMPOSSIBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6529543 ↗
• MalfunctionJul 1, 2016Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION OMNI-TOME. THE CUTTING WIRE BROKE. WHEN THEY TOOK IT OUT OF THE ENDOSCOPE, IT HAD SEPARATED FROM THE CATHETER AT THE TIP. THE WIRE DID NOT BECOME FREE INSIDE OF THE PATIENT'S BODY. THE WIRE CAME OUT OF THE SCOPE ATTACHED TO THE CATHETER IN ONE SPOT [ANCHOR SEPARATION WITHOUT DETACHMENT].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5764737 ↗