D.A.S.H. G34780Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002347806), received between Feb 21, 2017 and Nov 15, 2023 — classified as 3 malfunctions.

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

• MalfunctionNov 15, 2023Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE. IT WAS INITIALLY REPORTED DURING THE FIRST PASS WITH THE EXTRACTOR BALLOON, THE GUIDE WIRE BENT AND SUBSEQUENTLY WERE UNABLE TO USE IT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 STATING THAT CHANGE OF GUIDE WIRE FOR ANOTHER RE-CANNULATION WITH THE BALLOON EXTRACTOR (LOSS OF WIRE GUIDE ACCESS AND COATING DAMAGE). [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 18142266 ↗
• MalfunctionNov 17, 2021Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE COATING OF THE WIRE CAME OFF. A NEW PRODUCT WAS OPENED AND THE PROCEDURE WAS CARRIED OUT AS PLANNED. 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 12830978 ↗
• 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 6346334 ↗