Acrobat G47612Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002476127), received between Dec 7, 2017 and Oct 18, 2019 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THEY PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE CUSTOMER HAS STATED THAT THE HAVE HAD INCIDENT WHERE A WIRE HAS SHREDDED ITS OWN HYDROPHILIC COATING WHILST INSIDE A PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THE COATING DAMAGE WAS AT THE PATIENT END APPROXIMATELY. 20 CM FROM TIP THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 24 SEP 2019 AND IT WAS DETERMINED THAT THERE WAS COATING DAMAGE AT THE JOINT OF THE TIP AROUND 5.85 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 9208692 ↗
• MalfunctionAug 20, 2019Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THEY CANNULATED BILE DUCT WITH WIRE GUIDE AND SPHINCTEROTOME. ON REMOVAL OF SPHINCTEROTOME OVER WIRE GUIDE, THERE WAS RESISTANCE NOTICED ON THE EXCHANGE BY PHYSICIAN. ON REMOVAL OF SPHINCTEROTOME WITH WIRE [LOST WIRE GUIDE ACCESS], IT WAS NOTICED THAT THE COATING HAD COME OFF THE WIRE [COATING DAMAGE]. ADDITIONAL INFORMATION WAS RECEIVED ON 31-JUL-2019: THE COATING CAME OFF APPROXIMATELY 5-6 CM¿S FROM THE TIP OF THE WIRE. 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 8912632 ↗
• MalfunctionMar 4, 2019Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING A SPHINCTEROTOMY, THE PHYSICIAN USED TWO (2) COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDES. AT THE 5 CM HYDROPHILIC PORTION, THE WIRE HAD EXTRA PIECE OF PLASTIC [COATING DAMAGE] THAT CREATED A LUMP SO THEY WERE UNABLE TO ADVANCE IT THROUGH THE SPHINCTEROTOME. THE PROCEDURE HAD TO BE STARTED FROM THE BEGINNING DUE TO THIS ISSUE [RE-CANNULATION DUE TO LOST WIRE GUIDE ACCESS] (SUBJECT OF THIS REPORT AND SEE RELATED MDR 1037905-2019-00102). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 13-FEB-2019 FROM THE AREA REPRESENTATIVE: THE EXTRA PIECE OF PLASTIC WAS ALREADY ON THE WIRE BEFORE IT CAME INTO CONTACT WITH THE SPHINCTEROTOME OR THE PATIENT. I WILL BE RETURNING THE WIRES TODAY AND WITH THEM IS A BRAND NEW WIRE THAT I TOOK FROM THE ACCOUNT AND OPENED AT HOME FOR REFERENCE BUT WHEN I TOOK IT FROM THE RUNNER IT HAD EXACTLY THE SAME ISSUE AS THE WIRES THAT HAD BEEN LOADED INTO THE FUSION IDE-TOME SPHINCTEROTOME WITH DOMETIP [COATING DAMAGE] (ALSO SUBJECT OF THIS REPORT). THE FOLLOWING FURTHER CLARIFICATION WAS RECEIVED ON 13-FEB-2019 FROM THE COOK AREA REPRESENTATIVE: THE WIRES WERE NOT ALL INSPECTED AS FOR SOME OF THE PROCEDURES I WAS NOT IN THE ROOM AND THEY WERE LOADED BY T

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8388328 ↗
• MalfunctionMar 4, 2019Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING A SPHINCTEROTOMY, THE PHYSICIAN USED TWO (2) COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDES. AT THE 5 CM HYDROPHILIC PORTION, THE WIRE HAD EXTRA PIECE OF PLASTIC [COATING DAMAGE] THAT CREATED A LUMP SO THEY WERE UNABLE TO ADVANCE IT THROUGH THE SPHINCTEROTOME. THE PROCEDURE HAD TO BE STARTED FROM THE BEGINNING DUE TO THIS ISSUE [RE-CANNULATION DUE TO LOST WIRE GUIDE ACCESS] (SUBJECT OF THIS REPORT AND SEE RELATED 1037905-2019-00110). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 13-FEB-2019 FROM THE AREA REPRESENTATIVE: THE EXTRA PIECE OF PLASTIC WAS ALREADY ON THE WIRE BEFORE IT CAME INTO CONTACT WITH THE SPHINCTEROTOME OR THE PATIENT. I WILL BE RETURNING THE WIRES TODAY AND WITH THEM IS A BRAND NEW WIRE THAT I TOOK FROM THE ACCOUNT AND OPENED AT HOME FOR REFERENCE BUT WHEN I TOOK IT FROM THE RUNNER IT HAD EXACTLY THE SAME ISSUE AS THE WIRES THAT HAD BEEN LOADED INTO THE FUSION IDE-TOME SPHINCTEROTOME WITH DOMETIP (SEE RELATED MDR 1037905-2019-00110). THE FOLLOWING FURTHER CLARIFICATION WAS RECEIVED ON 13-FEB-2019 FROM THE AREA REPRESENTATIVE: THE WIRES WERE NOT ALL INSPECTED AS FOR SOME OF THE PROCEDURES I WAS NOT IN THE ROOM AND THEY WERE LOADED BY THE CLINICAL STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8388327 ↗
• MalfunctionFeb 18, 2019Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  THE DESCRIPTION OF EVENT WAS CORRECTED TO INCLUDE THE RELATED MDR REFERENCE: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDES. WHEN THE WIRE GUIDE WAS LOADED INTO THE FUSION NEEDLE KNIFE, IT WOULD NOT ADVANCE. THE WIRE HAD EXTRA PIECE OF PLASTIC WHICH MADE A RIDGE AT THE TIP [COATING DAMAGE]. THIS STOPPED IT [WIRE GUIDE] FROM ADVANCING ANY FURTHER. WE HAD TO TAKE THE NEEDLE KNIFE OUT AND RELOAD WITH ANOTHER WIRE, THAT MADE AN ALREADY DIFFICULT SITUATION EVEN MORE DIFFICULT WHEN IT WAS REMOVED [LOST WIRE GUIDE ACCESS]. YOU COULD SEE THAT AN EXTRA PIECE OF PLASTIC OF SOME DESCRIPTION [TYPE] WAS LEFT AT THE END OF THE HYDROPHILIC PORTION [COATING DAMAGE]. THE COOK SALES REPRESENTATIVE ADVISED THAT THIS SAME ISSUE HAS HAPPENED IN TWO (2) CASES. THE SAME ISSUE WAS REPORTED TO HAVE OCCURRED WITH TWO (2) DEVICES PRIOR TO USE AS WELL. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 13-FEB-2019 FROM THE AREA REPRESENTATIVE: THE EXTRA PIECE OF PLASTIC WAS ALREADY ON THE WIRE BEFORE IT CAME INTO CONTACT WITH THE SPHINCTEROTOME OR THE PATIENT. I WILL BE RETURNING THE WIRES TODAY AND WITH THEM IS A BRAND N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8347168 ↗
• MalfunctionDec 7, 2017Migration or Expulsion of Device; Peeled/Delaminated; Migration or Expulsion of Device; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED AN ACROBAT 2 CALIBRATED TIP WIRE GUIDE. DURING A DIFFICULT CANNULATION, THE POSITION WAS LOST ON MULTIPLE OCCASIONS [LOST WIRE GUIDE ACCESS]. THE WIRE WAS PULLED BACK INTO THE BALLOON TO RE-CANNULATE THE COMMON BILE DUCT (CBD), AND SUBSEQUENTLY CAME OUT OF THE ZIP PORT [IDE PORT]. THE PHYSICIAN WAS NOT AWARE OF THIS AND ATTEMPTED TO ADVANCE THE GUIDEWIRE. WHEN IT BECAME APPARENT THAT THE WIRE WAS OUTSIDE OF THE BALLOON CATHETER, THE WIRE GUIDE WAS PULLED BACK. IT STRIPPED [COATING DAMAGE] AT THE TIP, AS IT GOT CAUGHT ON THE BRIDGE. SCISSORS HAD TO BE USED TO DETACH THE WIRE GUIDE FROM THE ENDOSCOPE. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THERE IS 2 CM OF WIRE GUIDE COATING MISSING AND WAS NOT INCLUDED IN THE RETURN OF THE DEVICE. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING SECTION IS UNKNOWN.

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

  MAUDE report 7095703 ↗