Fusion G50976Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002509764), received between Jun 29, 2016 and Aug 19, 2016 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionAug 19, 2016Bent; Migration or Expulsion of Device; Bent; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION LOOP TIP WIRE GUIDE. AFTER A VERY DIFFICULT CANNULATION USING THE FUSION LOOP TIP WIRE GUIDE (INSTEAD OF THE PRE-LOADED WIRE GUIDE), THE SPHINCTEROTOME WAS HARD TO PEEL OFF [EXCHANGE]. FINALLY, THEY LOST ACCESS FROM THE BILE DUCT. THE WIRE GUIDE WAS BENT, SO IT COULD NOT BE USED ANYMORE. THEY HAD TO USE NEW PRODUCTS AND RE-CANNULATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5888880 ↗
• InjuryJun 29, 2016Fracture; Material Deformation; Fracture; Material Deformation

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK FUSION LOOP TIP WIRE GUIDE. THE DISTAL END OF THE WIRE UNRAVELED IN THE PSEUDOCYST. A PORTION OF THE DEVICE WAS REMOVED USING A PEDIATRIC BIOPSY FORCEP. A DIFFERENT WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 5759803 ↗