Acrobat G44217Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002442177), received between Feb 26, 2016 and Apr 8, 2016 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 8, 2016Peeled/Delaminated; Peeled/Delaminated

  ON (B)(6) 2016, WE RECEIVED THE FOLLOWING INFORMATION: DURING TWO (2) ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE CUSTOMER USED A FUSION IDETOME ON BOTH OCCASIONS. WHEN THE WIRE WAS LOCKED INTO PLACE THEN PASSED INTO THE SPHINCTEROTOME, AND THEN PASSED DOWN ENDOSCOPE, THE TIP OF THE WIRE HAD SLIPPED FORWARD OUT OF THE SPHINCTEROTOME. IT WAS LOCKED PROPERLY AS CHECKED BY THE SENIOR NURSE AFTER NURSE HAD SET IT UP. TWO COOK REPS ALSO PRESENT TO VERIFY THIS. ON 03/14/2016, ONE OF THE TWO DEVICES WAS RECEIVED FOR EVALUATION. THERE WAS COATING DAMAGE PRESENT ON THE DISTAL TIP OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5562747 ↗
• MalfunctionMar 28, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. DURING SEVERAL TRIES TO CANNULATE THE METAL STENT IN A QUITE NARROW ENVIRONMENT IN THE DUODENUM, THE WIRE GUIDE WAS MOVED SEVERAL TIMES BACK AND FORTH FROM THE SPHINCTEROTOME INSIDE THE PATIENT. WHEN TAKING THE DEVICES OUT [OF THE ENDOSCOPE] FOR TRYING ANOTHER SOLUTION [TECHNIQUE], WE SAW THAT THE COATING ON THIS WIRE GUIDE WAS PEELED OFF APPROXIMATELY 10 CM FROM TIP. THE COATING OF THE WIRE GOT STRIPPED OFF BY THE BRIDGE OF THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5530377 ↗
• MalfunctionFeb 26, 2016Peeled/Delaminated; Peeled/Delaminated

  AFTER SPHINCTEROTOMY AND WHEN THE GUIDE WIRE IS IN CDC [COMMON BILE DUCT, CBD], THE DOCTOR PEELED OFF THE SPHINCTEROTOME AND IT WAS VERY HARD TO DO IT [DIFFICULT TO PERFORM ZIP EXCHANGE]. THE GUIDE WIRE PEELED OFF THE DISTAL PART [COATING DAMAGE]. THE PHYSICIAN USED THE LONG TECHNIQUE AND ANOTHER WIRE GUIDE TO FINALIZE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5463856 ↗