D.A.S.H. G25666Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002256668), received between Aug 2, 2016 and Aug 31, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME (PRELOADED WITH A TRACER METRO DIRECT WIRE GUIDE). THE PHYSICIAN PERFORMED A SPHINCTEROTOMY. THE SPHINCTEROTOME WAS REMOVED AND THE WIRE GUIDE LEFT IN PLACE. THE USER BEGAN TO ADVANCE A COOK CYTOMAX CYTOLOGY BRUSH OVER THE WIRE. APPROXIMATELY HALF WAY DOWN THE WIRE, THEY WERE UNABLE TO ADVANCE ANY FURTHER. ADDITIONALLY, IT WAS IMPOSSIBLE TO RETRACT THE BRUSH BACK OVER THE WIRE. THE CYTOLOGY BRUSH AND WIRE GUIDE WERE REMOVED TOGETHER [LOSS OF WIRE GUIDE ACCESS]. ANOTHER WIRE WAS USE TO RECANNULATE THE DUCT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7839134 ↗
• MalfunctionSep 1, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE PAPILLOTOME PRESENTED A LEFT CURVATURE [INCORRECT CUTTING WIRE ORIENTATION] THAT PREVENTED THE CANNULATION OF THE DUODENAL PAPILLA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6837428 ↗
• MalfunctionAug 28, 2017Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE USER TRIED TO PULL THE ANCHOR TO ADJUST THE DIRECTION TO CANNULATION [THE USER ATTEMPTED TO BOW THE SPHINCTEROTOME]. THEN THE ANCHOR [CUTTING WIRE SECURING COMPONENT] SEPARATED FROM THE CATHETER. [THE USER] WITHDREW THE DEVICE AND REPLACED [IT WITH A] NEW ONE INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6823702 ↗
• MalfunctionAug 11, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. DURING THE ERCP, THE USER OPERATED THE CANNULATION SUCCESSFULLY AND ADVANCED THE BASKET TO FETCH THE STONE AFTER WITHDRAWING THE WIRE GUIDE. THEN THEY TRIED TO INSERT THE WIRE GUIDE THROUGH WIRE GUIDE LUMEN BUT IT FAILED TO GO THROUGH IT. THE TIP OF WIRE GUIDE WAS FOUND THAT THE COVERING ACCORDIONED OR FRAYED ON CORE WIRE [WIRE GUIDE COATING DAMAGE]. THE USER REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6789545 ↗
• MalfunctionMar 6, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK DASH DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE PHYSICIAN WAS EVALUATING THE DASH SPHINCTEROTOME AND NOTED A VISIBLE DISORIENTATION OF THE CANNULA BETWEEN THE 9-10 O'CLOCK POSITION. THIS RESULTED IS SEVERAL FAILED ATTEMPTS TO GAIN ACCESS [TO THE PAPILLA], HOWEVER THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6380384 ↗
• MalfunctionFeb 13, 2017Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK DASH DOMETIP DOUBLE LUMEN SPHINCTEROTOMES. THE CUTTING WIRE WAS NOT INTACT ON BOTH DEVICES [CUTTING WIRE BREAKS IN ONE LOCATION WITHOUT DETACHMENT]. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE COMPLAINT DID NOT CONTAIN REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE COOK AREA REPRESENTATIVE ON 1/19/17: "I SPOKE WITH SEVERAL STAFF ABOUT THIS. THEY WERE USING AN OLD ENDOSTAT II FOR THE SPHINCTEROTOMY. THEIR CURRENT CONMED GENERATOR IS BROKEN AND HAD NOT USED THE ENDOSTAT II FOR AN ERCP BEFORE. THEY WERE NOT SURE FOR THE ACTUAL SETTINGS TO USE. THEY DID NOT FEEL LIKE IT WAS CUTTING WITH THE SETTINGS THEY WERE USING. ONE PERSON SAID IT WAS SET ON PURE CUT AND 35 WATTS. ANOTHER PERSON SAID IT WAS PURE CUT AND 40 WATTS. THE LIMITED INFORMATION THEY HAD WAS TO USE 40 TO 50 WATTS WITH PURECUT. THEY DID CHECK THE CUTTING WIRE BEFORE ON EACH DASH AND IT WAS INTACT. WHEN I PICKED THEM UP TODAY, THE CUTTING WIRE HAD PULLED OUT OF THE DISTAL END OF THE CATHETER [CUTTING WIRE SECURING COMPONENT/ANCHOR SEPARATES FROM CATHETER]. THE WIRE DOES N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6326871 ↗
• MalfunctionAug 2, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: "THE PAPILOTOME PRESENTED A DEFORMITY IN ITS DISTAL TIP [INCORRECT CUTTING WIRE ORIENTATION]. THE PROCEDURE COULD NOT BE DONE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5839833 ↗