D.A.S.H. G54193Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002541931), received between Apr 14, 2016 and Jun 23, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2017Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK DASH DOMETIP DOUBLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: "THE CUT WIRE BROKE DURING THE PROCEDURE, THE PHYSICIAN HAD TO USE ANOTHER DEVICE." THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 5/30/17. IT WAS OBSERVED THAT PART OF THE DISTAL END OF THE CATHETER HAD BEEN CUT AND WAS NOT INCLUDED IN THE DEVICE RETURN. IT WAS ALSO OBSERVED THE DISTAL PORTION OF THE CUTTING WIRE WAS MISSING AND NOT INCLUDED IN THE RETURN. IT IS CURRENTLY UNKNOWN IF THE MISSING PIECE OF CUTTING WIRE WAS CUT ALONG WITH THE CATHETER.

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

  MAUDE report 6664027 ↗
• MalfunctionAug 5, 2016Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. DURING THE PROCEDURE, THE CUTTING WIRE SEPARATED FROM THE END OF THE SPHINCTEROTOME. NOTHING DETACHED INSIDE THE PATIENT [CUTTING WIRE BREAKS IN ONE LOCATION WITHOUT DETACHMENT]. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT. THE DEVICE WAS RECEIVED ON 07/13/2016 FOR EVALUATION. THE CUTTING WIRE SECURING COMPONENT HAS SEPARATED FROM THE CATHETER OF THE DEVICE. NO PORTION OF THE DEVICE IS MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5849700 ↗
• MalfunctionApr 14, 2016Material Separation; Material Separation

  ON (B)(4) 2016, THE FOLLOWING INFORMATION WAS REPORTED TO A COOK REPRESENTATIVE: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE CUSTOMER TRIED TO CUT THE PAPILLA. THE CUTTING WIRE DETACHED/TORN OFF ON ONE END [CUTTING WIRE BREAKS, ONE LOCATION] OF THE SPHINCTEROTOME. ON (B)(4) 2016, WE RECEIVED THE FOLLOWING INFORMATION: THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF THE DEVICE. IT IS REPORTED THAT THE ANCHOR DID NOT DETACH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5578530 ↗