Acrobat G32759Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002327597), received between Aug 25, 2017 and Feb 2, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 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 2, 2018Break; Break

  DURING A GASTROSCOPY, THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE WIRE WAS BROKEN INTO TWO (2) PARTS WHEN WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S GUIDEWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7238021 ↗
• MalfunctionAug 25, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. DURING THE OPERATION [PROCEDURE], THE USER RETAINED THE WIRE GUIDE AND TRIED TO WITHDRAW THE SPHINCTEROTOME, BUT IT MET SOME RESISTANCE IN THE PROCESS. THE USER INJECTED SOME SALINE THROUGH THE CONTRAST LUMEN AND CONTINUED TO WITHDRAW THE SPHINCTEROTOME. THEN THE PORTION WHICH WAS ABOUT 12 CM FROM THE TIP OF WIRE GUIDE WAS FOUND FOLDED UNDER THE ENDOSCOPE. NO PORTION OF DEVICE WAS DETACHED AND LEFT INSIDE PATIENT BODY. REPLACED WITH A NEW WIRE GUIDE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819967 ↗