D.A.S.H. G25790Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002257900), received between Apr 14, 2016 and Mar 11, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. IT WAS REPORTED THAT THE WIRE GUIDE COATING PEELED OFF DURING THE CASE. PHOTO OF DEVICE SHOWING THE WIRE GUIDE COATING DAMAGE WAS PROVIDED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21576227 ↗
• MalfunctionNov 1, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE DEVICE CAME OUT THE DISTAL END OF THE ENDOSCOPE, THE ORIENTATION WAS IN THE 9 O'CLOCK POSITION [INCORRECT CLOTTING ORIENTATION]. THE PHYSICIAN TRIED BRIEFLY TO MANIPULATE THE DEVICE AND ENDOSCOPE WHILE THEY WERE WAITING FOR ANESTHESIA, BUT EVENTUALLY PULLED IT OUT AND USED ANOTHER OF THE SAME PRODUCT. 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 9268348 ↗
• MalfunctionOct 24, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN. WHEN THE DEVICE WAS PUT DOWN THE ENDOSCOPE THE DEVICE WAS BOWING AT THE WRONG ANGLE [INCORRECT CUTTING WIRE ORIENTATION]. PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER OF THE SAME DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS 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 9233923 ↗
• MalfunctionMay 11, 2018Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE CUTTING WIRE BROKE. THE PHYSICIAN OPENED ANOTHER DEVICE, AND USED IT SUCCESSFULLY. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 04/17/2018. THE CUTTING WIRE SECURING COMPONENT HAD SEPARATED FROM THE CATHETER AND A PORTION WAS MISSING. THE FOLLOWING WAS RECEIVED FROM THE COOK SALES REPRESENTATIVE ON 04/18/2018: [THE COOK SALES REPRESENTATIVE] WAS IN THE ERCP PROCEDURE AND IS CONFIDENT THAT NOTHING WAS LEFT INSIDE THE PATIENT. IT IS POSSIBLE THAT PART OF THE DEVICE FELL OUT OF THE ENDOSCOPE AS IT WAS BEING REMOVED.

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

  MAUDE report 7508340 ↗
• MalfunctionMar 2, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE WIRE COATING BEGAN TO STRIP OFF NEAR THE DISTAL END. NO PORTION CAME OFF IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7309097 ↗
• MalfunctionApr 24, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK DASH DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE DOCTOR STATED THAT THE CATHETER TIP CAME OUT AT A HORRIBLE ANGLE (ORIENTATION OFF).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6516451 ↗
• MalfunctionNov 21, 2016Peeled/Delaminated; Peeled/Delaminated

  THE FOLLOWING WAS REPORTED TO COOK BY THE CUSTOMER: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THEY TOOK THE PRE-LOADED WIRE GUIDE OUT OF THE DUCT AND NOTICED THAT THE COATING OF THE DISTAL TIP AND THE COATING OF THE BODY OF THE GUIDE WIRE HAD SEPARATED. THEY LOOKED FOR DEBRIS [DETACHED PORTIONS OF THE DEVICE] BUT DID NOT FIND ANY. THEY COULD NOT FIND ANY EVIDENCE OF ANY COATING DETACHING INSIDE OF THE PATIENT. A MEDWATCH REPORT MW5065721 WAS RECEIVED ON 11/14/2016 AND STATED THE FOLLOWING: "AT THE END OF ERCP CASE, DURING ROUTINE INSPECTION PRIOR TO THE PATIENT LEAVING THE OPERATING ROOM, A PIECE OF THE COATING OF THE WIRE GUIDE APPEARED TO BE MISSING. THE OPERATING ROOM TEAM HAD NEPTUNE REP COME AND SEARCH THE SUCTION FILTER. NO REMNANTS OF GUIDE WIRE COATING NOTED, X-RAY PERFORMED WITH NO SIGNS OF GUIDE WIRE COATING. THE DOCTOR PERFORMED A THOROUGH SEARCH WITH THE SCOPE AND NOTHING WAS FOUND. PATIENT TRANSFERRED TO THE PACU AND RECOVERED AS EXPECTED. THE COOK REP CALLED, THE GUIDE IS A COOK PRODUCT CALLED HOWELL D.A.S.H. SPHINCTEROTOME AND HE TOLD THAT THE SHEATH SOMETIMES FOLDS BACK ON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6116608 ↗
• MalfunctionOct 10, 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. THE PHYSICIAN ATTEMPTED TO CANNULATE WITH A SPHINCTEROTOME. HE EASILY PASSED THE DEVICE THROUGH THE ENDOSCOPE, BUT THE DEVICE HAD POOR ORIENTATION AND WAS POINTED "TO THE LEFT" AND NOT TOWARDS THE PAPILLA. THEY PROCEEDED WITH A NEW D.A.S.H. SPHINCTEROTOME AND COMPLETED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6015190 ↗
• MalfunctionJun 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. THE ORIENTATION WAS TO THE 9 O'CLOCK POSITION. THEY TRIED TO CANNULATE BUT THE ORIENTATION WAS POOR. THEY USED A DIFFERENT DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5695546 ↗
• MalfunctionApr 14, 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. THERE WAS A PROBLEM WITH THE TIP. IT WAS DEFORMED AND PROJECTED IN THE WRONG DIRECTION [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5575924 ↗