D.A.S.H. G34778Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002347783), received between Jun 24, 2016 and Aug 10, 2021 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE AND INITIALLY STATED THAT THE PAPILLOTOME RIPPED WHEN USED. PER CLARIFICATION RECEIVED ON 10 JUNE 2021: THE CUTTING WIRE BROKE WHEN THE CUSTOMER TENSED IT. OUR EVALUATION OF THE RETURNED DEVICE ON 13 JULY 2021 DETERMINED THAT THE CUTTING WIRE SECURING COMPONENT LOCATED NEAR THE DISTAL END OF THE SPHINCTEROTOME HAS DISCONNECTED FROM THE CATHETER [SUBJECT OF REPORT]. 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 12300108 ↗
• MalfunctionAug 14, 2020Malposition of Device; Malposition of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE. THE TIP AND CUTTING WIRE OF THE PRODUCT WAS BENT. THE ADDITIONAL INFORMATION RECEIVED INDICATED THE CUTTING WIRE WAS INCORRECTLY ORIENTED [SUBJECT OF THIS REPORT]. 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 10410553 ↗
• MalfunctionOct 3, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H.® PRELOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. ERCP STONE EXTRACTION WENT OKAY WITH AN EXTRACTION BALLOON. AFTER THE PROCEDURE (WAS READY), IT WAS DETERMINED THE COATING FROM THE WIRE GUIDE DETACHED. NOTHING WAS LEFT IN THE BODY AND THE WIRE WAS DISPOSED OF. THE COATING DAMAGE OCCURRED AT 15 CM BEHIND THE PATIENT END FOR 20 CM. 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 9153611 ↗
• MalfunctionFeb 8, 2019Peeled/Delaminated; Use of Device Problem; Positioning Problem; Peeled/Delaminated; Use of Device Problem; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE. THEY DID A SPHINCTEROTOMY. THEY REMOVED THE SPHINCTEROTOME AND LEFT THE WIRE IN PLACE. THEY PROCEEDED TO PUT THE EXTRACTION BALLOON ON THE WIRE. THEY FELT RESISTANCE BUT KEPT ON PUSHING THE BALLOON OVER THE WIRE. A PORTION OF THE COATING THEN STRIPPED OFF OF THE WIRE INSIDE THE PATIENT (SUBJECT OF THIS REPORT). THEY STOPPED AND PULLED EVERYTHING OUT [LOST WIRE GUIDE ACCESS]. THE COATING DID NOT DETACH FROM THE WIRE AND CAME OUT WITH THE WIRE. NOTHING REMAINED IN THE PATIENT. THEY THEN USED ANOTHER WIRE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE CUSTOMER SAID THAT THE PROBLEM EXPERIENCED, OCCURRED THREE (3) OTHER TIMES OVER THE HOLIDAYS FROM UNKNOWN LOTS (SEE RELATED MDR 1037905-2019-00048). 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 8319867 ↗
• MalfunctionNov 2, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK DASH PRELOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOMES. TWO (2) PRIOR TO USE DEVICES WERE ALSO REPORTED. [THE USER HAD A] PROBLEM WITH ORIENTATION OF THE SPHINCTEROTOME WHEN EXITING THE OPERATING CHANNEL OF THE ENDOSCOPE. THE NURSE CAREFULLY REMOVED THE SPHINCTEROTOME FROM THE PACKAGE AND REMOVED THE STYLET FROM THE DASH TIP. [THE NURSE] IRRIGATED THE PHYSIOLOGICAL SERUM [SALINE] INTO THE CATHETER AND GAVE THE DEVICE TO THE PRACTITIONER WHO INTRODUCED IT WITHOUT ANY PROBLEM INTO THE OPERATING CHANNEL OF THE ENDOSCOPE; [BUT THE SPHINCTEROTOME] CAME OUT TWISTED [INCORRECT CUTTING WIRE ORIENTATION]. THE NURSE TOOK ANOTHER SPHINCTEROTOME FROM THE SAME LOT. THE SAME PROBLEM OF ORIENTATION WITH A CUTTING THREAD COMPLETELY RETURNED [INCORRECT CUTTING WIRE ORIENTATION]. THE PRACTITIONER THEN USED ANOTHER MANUFACTURER¿S SPHINCTEROTOME WITHOUT ORIENTATION PROBLEMS. 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 T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8035004 ↗
• MalfunctionApr 2, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK DASH PRELOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE PRODUCT [SPHINCTEROTOME] WAS PUSHED THROUGH THE WORKING CHANNEL WITHOUT FIRST MANIPULATING THE TIP. THE TIP WAS IN THE WRONG POSITION [INCORRECT CUTTING WIRE ORIENTATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7388829 ↗
• MalfunctionNov 29, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H PRELOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE PROBLEM IS WITH THE PRELOADED WIRE GUIDE. THE PLASTIC COATING CAME AWAY FROM THE CORE OF THE WIRE. IT DID NOT DETACH FROM THE WIRE. NOTHING HAD TO BE RETRIEVED. THE WIRE COULD NOT BE USED AND HAD TO BE REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER WIRE GUIDE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 11/14/17: THE WIRE WAS DAMAGED AT THE PATIENT END WITHIN THE 10 CM RANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068060 ↗
• MalfunctionMar 10, 2017Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. PRELOADED WITH ACROBAT WIRE GUIDE. THE PRODUCT WAS PUSHED THROUGH THE WORKING CHANNEL WITHOUT FIRST MANIPULATING THE TIP, THEN THE WIRE WAS PULLED TO RAISE THE POINT, AND THE CUTTING WIRE WAS TORN [CUTTING WIRE BROKE]. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 2/14/17, AND IT WAS NOTED THAT THE CUTTING WIRE WAS BROKEN AND A SECTION OF THE CUTTING WIRE IS MISSING.

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

  MAUDE report 6394846 ↗
• MalfunctionFeb 21, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK DASH PRE-LOADED ACROBAT WITH WIRE GUIDE. DURING THE PROCEDURE, THE WIRE GUIDE COATING STRIPPED OFF OF THE WIRE [COATING DAMAGE]. THE FOLLOWING INFORMATION WAS PROVIDED ON 2/2/17: "ALL THE DAMAGE OCCURRED AT THE PATIENT END OF THE WIRE WITHIN 20-25 CM FROM THE TIP."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6346252 ↗
• MalfunctionOct 11, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE. AS REPORTED TO CUSTOMER RELATIONS, "THE WIRE STRIPPED [COATING DAMAGE]. THE FACILITY ELECTED TO OPEN UP ANOTHER MANUFACTURER'S WIRE GUIDE TO COMPLETE THE INTENDED PROCEDURE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6017445 ↗
• MalfunctionJun 24, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK D.A.S.H. PRE-LOADED WITH ACROBAT WIRE GUIDE. PER THE COMPLAINT REPORTING FORM: "THE CONSULTANT GAINED ACCESS TO THE COMMON BILE DUCT BY USING THE SPHINCTEROTOME AND WIRE. ONCE HE WAS HAPPY WITH THE WIRE POSITION HE EXCHANGED THE SPHINCTEROTOME. IN ORDER TO MAINTAIN ACCESS TO THE BILE DUCT, THE DOCTOR SECURED THE WIRE ON THE LOCKING DEVICE. HE THEN ADVANCED THE BILIARY METAL STENT OVER THE WIRE TO PLACE IN THE BILE DUCT. UNFORTUNATELY THIS WASN'T POSSIBLE STRAIGHT AWAY DUE TO THE STRICTURE BEING TOO TIGHT SO HE EXCHANGED THE STENT FOR A BILIARY DILATATION BALLOON. DURING THIS EXCHANGE HE NOTICED THAT THE WIRE COATING HAD STARTED TO COME OFF WHERE IT WAS LOCKED IN THE LOCKING DEVICE. HE CONTINUED TO PLACE THE METAL STENT WITH THE DAMAGED WIRE. AFTER THE PROCEDURE IT WAS OBVIOUS THAT THE COATING HAD COME OFF THE WIRE EVEN MORE THAN JUST AT THE LOCKING DEVICE POSITION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5748989 ↗