D.A.S.H. G25227Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002252271), received between Nov 17, 2016 and Oct 21, 2019 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOMES. THE FOLLOWING WAS REPORTED ON (B)(6) 2019: "THE TIP IS DEFORMED (BENT) CONTAMINATED REMOVED FROM PACKAGING [TIP BENT WRONG WAY PRIOR TO USE]." THE FOLLOWING WAS REPORTED ON 15-OCT-2019: OUT OF THE PACKAGING, THE CUTTING WIRE WAS BENT. AFTER THE DEVICE WAS INSERTED INTO THE ENDOSCOPE, IT WAS NOTED THAT THE CUTTING WIRE ORIENTATION WAS INCORRECT. 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 9216205 ↗
• MalfunctionAug 5, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE CUTTING WIRE WAS NOT STRAIGHT [TIP POINTING IN THE WRONG DIRECTION]. THEY HAD TO OPEN A NEW ONE TO FINISH THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8861764 ↗
• MalfunctionDec 14, 2018Failure 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 TIP OF THE SPHINCTEROTOME WAS DEVIATED TO THE RIGHT SIDE [INCORRECT CUTTING WIRE ORIENTATION] DURING THE ELEVATION OF THE ENDOSCOPE. THE PHYSICIAN USED ANOTHER D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. 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 8165029 ↗
• MalfunctionSep 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 DEVICE WAS ADVANCED TO DESIRED POSITION AND THE USER PULLED [BOWED] THE CUTTING WIRE, BUT THE HEAD OF THE CUTTING WIRE BROKE. THE USER CHANGED TO ANOTHER SAME DEVICE TO FINISH THE PROCEDURE WITH NO ISSUE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED ON 20-AUG-2018. THE INVESTIGATION DETERMINED THAT THE CUTTING WIRE SECURING COMPONENT HAD SEPARATED. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THAT APPROXIMATELY 3 MM OF THE SECURING COMPONENT IS MISSING AND WAS NOT INCLUDED IN THE RETURN OF THE DEVICE. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING SECTION IS UNKNOWN. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION IS UNKNOWN. 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: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7865488 ↗
• MalfunctionJul 16, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. A PATIENT WITH A PLASTIC STENT IN PLACE, WAS SCHEDULED FOR AN ERCP WITH STENT REMOVAL. A DASH PRELOADED WITH METRO DIRECT WIRE GUIDE SPHINCTEROTOME WAS ADVANCED THROUGH THE DUODENOSCOPE FOR CANNULATION NEXT TO THE EXISTING STENT. IT WAS NOTED THAT THE SPHINCTEROTOME'S ORIENTATION APPEARED TO BE "OFF" [INCORRECT CUTTING WIRE ORIENTATION]. [THE USER WAS] UNSURE IF THAT WAS DUE TO THE SPHINCTEROTOME OR THE POSITIONING DUE TO THE STENT IN PLACE. THE PHYSICIAN ADJUSTED HIS DUODENOSCOPE POSITION AND PUSHED OUT THE SPHINCTEROTOME AGAIN. THE SPHINCTEROTOME ORIENTATION WAS STILL POINTING TO THE 3 O'CLOCK POSITION. A NEW DASH SPHINCTEROTOME WAS OPENED AND ADVANCED THROUGH THE DUODENOSCOPE. THE ORIENTATION WAS POINTING TOWARDS 11 AND 12 O'CLOCK AS DESIRED. 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 7689974 ↗
• MalfunctionJun 12, 2018Failure 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 CUSTOMER REPORTED THAT THE CURVE WAS BROKEN. AN UPDATE ON 05/24/2018 WAS PROVIDED BY THE SALES REPRESENTATIVE. THEY PUT THE DEVICE THROUGH THE ENDOSCOPE. WHEN THE DEVICE EXITED THE DISTAL END OF THE ENDOSCOPE, THE ORIENTATION WAS OFF. THE CUSTOMER COULD NOT CONFIRM WHAT THE POSITION OF THE INCORRECT ORIENTATION WAS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7590892 ↗
• MalfunctionJul 7, 2017Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) , THE PHYSICIAN USED A COOK DASH DOMETIP DOUBLE LUMEN SPHINCTEROTOME. DURING THE INITIAL BOWING OF THE DEVICE, THE DISTAL END OF THE CUTTING WIRE DISLODGED FROM THE DISTAL END OF THE CATHETER [CUTTING WIRE SECURING COMPONENT SEPARATED FROM CATHETER]. A NEW DASH-480 WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6693062 ↗
• MalfunctionFeb 14, 2017Material Separation; Material Separation

  PRIOR TO AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN WAS PREPARING TO USE A COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. UPON OPENING THE DEVICE AND TESTING THE SPHINCTEROTOME, THE CUTTING WIRE LEFT ITS PLACE AT THE DISTAL TIP, THERE WERE NO TEAR OR CUTS [CUTTING WIRE SECURING COMPONENT SEPARATES FROM CATHETER]. IT WAS NEVER USED IN THE PATIENT. AS A HOSPITAL PROTOCOL, THE ELECTROSURGICAL UNITS FITTED TO TEST ITS OPERATION BEFORE ENTERING THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330537 ↗
• MalfunctionFeb 10, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK DASH DOMETIP DOUBLE LUMEN SPHINCTEROTOME. THE SPHINCTEROTOME WAS NOT THE RIGHT DIRECTION. THE ORIENTATION WAS BETWEEN EIGHT (8 O'CLOCK ) AND THREE (3 O'CLOCK) [INCORRECT CUTTING WIRE ORIENTATION]. A NEW SPHINCTEROTOME WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6321760 ↗
• MalfunctionJan 20, 2017Detachment Of Device Component; Detachment Of Device Component

  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 DEVICE WAS ADVANCED THROUGH THE ENDOSCOPE AND MET RESISTANCE. THE PHYSICIAN REMOVED THE DEVICE AND NOTED A PIECE OF WIRE/FIBER AT THE END OF THE DEVICE WHICH WAS NOT NOTED DURING PREP TIME. A SECOND DEVICE WAS USED WITH NO FURTHER COMPLICATIONS." DURING THE DEVICE EVALUATION ON (B)(6) 2016, IT WAS NOTED THAT THE DISTAL TIP OF THE PRELOADED WIRE GUIDE HAD DETACHED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED 1/19/17 FROM THE AREA REPRESENTATIVE: "THEY DID NOT RECALL ABOUT THE TIP OF THE WIRE. THEY DID NOT NOTICE ANY PART BEING LEFT IN THE PATIENT. THEY DO USE OLYMPUS ENDOSCOPES AND SOMETIMES THE WIRE GUIDE DOES GET STRIPPED WHEN THEY DO NOT PUT THE ELEVATOR ALL THE WAY DOWN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6267258 ↗
• MalfunctionJan 6, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: "A BURR/FLAW WAS NOTED TO BE ON THE END OF THE CATHETER. THE PHYSICIAN WAS ABLE TO PROCEED TO USE THE PRODUCT AND SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT. IT JUST MADE CANNULATION MORE DIFFICULT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6228558 ↗
• MalfunctionNov 17, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED FIVE (5) COOK D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOMES. WHILE LOADING THE SPHINCTEROTOMES THROUGH THE ENDOSCOPE, THE TIPS EXTENDED CROOKED [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6109134 ↗