D.A.S.H. G34779Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002347790), received between Oct 21, 2016 and Feb 28, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK DASH PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. AFTER SEVERAL EXCHANGES, THE COATING AROUND THE WIRE GUIDE BEGAN TO STRIP OFF REVEALING THE CORE OF THE WIRE GUIDE [COATING DAMAGE]. THE TECHNICIAN NOTICED ON FLUOROSCOPY WHAT LOOKED LIKE A SPRING AT THE TIP OF THE WIRE GUIDE. THEY REMOVED IT AND REALIZED THE COATING HAD STRIPPED OFF. THE WIRE GUIDE WAS INTACT, NO PIECES OR PARTS BROKE OFF, AND THERE WAS NOTHING LEFT BEHIND IN THE PATIENT NOR WAS THERE ANY HARM TO THE PATIENT AS A RESULT OF THE WIRE STRIPPING. THEY WERE ABLE TO USE ANOTHER WIRE AND COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6364348 ↗
• MalfunctionOct 21, 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. THE TIP OF THE WIRE GUIDE GOT [A] TEAR [COATING DAMAGE AT DISTAL END]. SUBSEQUENTLY, THE DEVICE WAS REMOVED FROM THE PATIENT [DEVICE WAS TAKEN OUT DUE TO THE COATING DAMAGE].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6048400 ↗