Acrobat G47614Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002476141), received between Jun 5, 2017 and Jun 3, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT¿ 2 CALIBRATED TIP WIRE GUIDE. IT WAS REPORTED THAT HE SHEATH OF THE GUIDE WIRE BECAME DETACHED FROM THE WIRE AND THAT THIS PROBABLY HAPPENED WHILE CHANGING THE ERCP CATHETER - TOO MUCH TENSION ON THE CATHETER. THE WIRE WAS SPRAYED WITH SILICONE SPRAY. 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 22135529 ↗
• MalfunctionOct 4, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. IT WAS NOTICED THAT THE WIRE COATING SEPARATED FROM THE INNER CORE NEAR WHERE IT EXITED THE ENDOSCOPE. WE WERE PLACING A PLASTIC STENT (OACL10-7). THE DAMAGE DID NOT IMPEDE THE PLACEMENT OF THE STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE WIRE WAS EXAMINED AND SEEMED TO HAVE DAMAGE TO IT, HENCE THIS COMPLAINT. 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 9157380 ↗
• MalfunctionMay 3, 2019Positioning Problem; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE SPHINCTEROTOME WAS NOT STRIPPING, AND WAS PULLING THE WIRE GUIDE OUT OF THE WIRE LOCK HALF WAY THROUGH THE EXCHANGE. ACCESS WAS LOST (PER THE COOK SALES REPRESENTATIVE, THIS WAS NOT DUE TO THE DEVICE), SO THE WIRE GUIDE HAD TO BE PLACED BACK INTO THE SPHINCTEROTOME. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. 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 8579115 ↗
• MalfunctionFeb 18, 2019Positioning Problem; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED AN ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE DEVICE IS SCRUNCHING UP. WHEN TRYING TO PULL OUT THE SPHINCTEROTOME, THE DEVICE [WIRE GUIDE] STARTED COMING OUT; [THERE WAS] SCRUNCHING AND CRUMPLING IN THE MIDDLE OF THE DEVICE, ROUGHLY. IT COULD BE THE COATING THAT IS CRUMPLED UP. IT SEEMED LIKE EVERYTHING WAS PROGRESSING NICELY PRIOR TO THAT (THEY HAD COMPLETED ONE EXCHANGE ALREADY). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 25-JAN-2019: THE PHYSICIAN REMOVED THE SPHINCTEROTOME AND WIRE, USED ANOTHER MANUFACTURER'S EQUIPMENT INSTEAD AND COMPLETED THE PROCEDURE [LOST WIRE GUIDE ACCESS]. 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 8348262 ↗
• MalfunctionDec 13, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE COATING ON THE WIRE STRIPPED. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. 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 8159536 ↗
• MalfunctionNov 30, 2018Positioning Problem; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE WIRE WAS INTRODUCED TO GET ACCESS TO THE COMMON BILE DUCT. DURING EXCHANGE OF A COOK FUSION EXTRACTION BALLOON, THE WIRE COATING STRIPPED. THE DEVICES WERE REMOVED [LOST WIRE GUIDE ACCESS] AND THE COATING WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A COMPETITIVE 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 8119997 ↗
• MalfunctionOct 15, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE COATING CAME OFF WIRE GUIDE APPROX 5-6 CMS FROM TIP. 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 7964958 ↗
• MalfunctionAug 31, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE OUTSIDE OF WIRE WAS PEELING OFF (SUBJECT OF THIS REPORT). THE COATING OF THE WIRE WAS PEELING OFF DURING USE AND THIS IS NOT THE FIRST ONE (SEE RELATED MDR 1037905-2018-00384). ACCORDING TO CUSTOMER THE COATING DID NOT PEEL OFF BECAUSE OF CONTACT WITH THE ELEVATOR OF THE ENDOSCOPE. THE FOLLOWING CLARIFICATION WAS RECEIVED ON 08-AUG-2018: THEY SAY THEY HAVE HAD MORE WIRES WHERE THE COATING OF THE WIRE HAS BEEN PEELING OFF THAT THEY JUST HAVE NOT PUT ASIDE (SEE RELATED MDR 1037905-2018-00384). THE WIRE GUIDE DAMAGE WAS AT THE PATIENT END, CLOSE TO THE TIP, AND I AM NOT ABLE TO PROVIDE MORE DETAILS (SUBJECT OF THIS 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 Consequences Or Impact To Patient

  MAUDE report 7838020 ↗
• MalfunctionJun 1, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE SPHINCTEROTOME EXCHANGE WAS DIFFICULT BECAUSE OF RESISTANCE WITH THE WIRE GUIDE. WIRE GUIDE [ACCESS] WAS LOST FROM THE PANCREATIC DUCT DUE TO THIS RESISTANCE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 05/16/2018: AFTER WIRSUM [PANCREATIC DUCT] CANNULATION, THE SPHINCTEROTOME WAS BEING EXCHANGED FROM A WIRE GUIDE (LOCKING ELEVATOR OF DUODENOSCOPE V SYSTEM), BUT A LOT OF RESISTANCE WAS ENCOUNTERED WHEN PERFORMING THE WIRE GUIDE EXCHANGE FROM THE SPHINCTEROTOME. BECAUSE OF THIS, THE WIRE GUIDE WAS PULLED OUT FROM THE WIRSUM. THIS CAUSED A LOT OF EXTRA TIME IN THE OPERATING ROOM (OR).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7560536 ↗
• MalfunctionApr 13, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED FIVE (5) TOTAL ACROBAT 2 CALIBRATED TIP WIRE GUIDES FROM LOT W3994086 [SEE RELATED MDR 1037905-2018-00143] AND W3926765 [SUBJECT OF THIS REPORT]. THE QUANTITY FROM EACH LOT IS UNKNOWN. THE WIRE WAS INSERTED AND THE PLASTIC COATING WAS UNRAVELING AND GETTING STUCK WITHIN THE ENDOSCOPE. THE USER TRIED NUMEROUS TIMES AND THE SAME THING WAS HAPPENING. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 03/29/2018: THE COATING ON FIVE (5) OF THEIR WIRES SHREDDED FROM THE 5 CM MARK UPWARDS. THEY KEPT TWO (2) OUT OF THE FIVE (5) TO BE RETURNED. THE DOCTOR COULD NOT CONFIRM THAT THE TIP WAS WET BEFORE ENTERING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7428751 ↗
• MalfunctionFeb 16, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. FOR NO EVIDENT REASON DURING THE MIDDLE OF THE EXCHANGE, THE WIRE SPLIT. NOTHING DETACHED AND THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THIS WIRE. PER EMAIL FROM PHYSICIAN: THE AREA REPRESENTATIVE WAS IN THE ROOM WHEN THIS HAPPENED. THE PATIENT WAS NOT AT RISK AT ANY MOMENT, BUT WHAT WE SAW WAS DEFINITELY VERY UNUSUAL. WE WERE ABLE TO DEPLOY A METAL STENT OVER THAT WIRE WITH NO DIFFICULTIES AT ALL. BASED ON THE PICTURE PROVIDED, THE COATING DAMAGE STARTED AT THE 12 CM SILVER MARK. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 01/22/18 AND THERE IS COATING DAMAGE AT 5.5 CM, EXPOSING THE CORE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7277727 ↗
• MalfunctionFeb 9, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE DEVICE WAS LOADED INTO A COOK FUSION QUATTRO EXTRACTION BALLOON AND THE BALLOON WAS ADVANCED INTO THE ENDOSCOPE APPROXIMATELY TWO (2) INCHES. THE PHYSICIAN THEN ADVANCED THE WIRE GUIDE DOWN THE ENDOSCOPE TO THE ELEVATOR. UPON ADVANCING THE EXTRACTION BALLOON, THE PHYSICIAN NOTED EXTREME DIFFICULTY IN ADVANCING THE BALLOON OUT OF THE ENDOSCOPE. HE THEN ATTEMPTED TO REMOVE THE BALLOON AND WIRE GUIDE, BUT ENCOUNTERED EXTREME RESISTANCE. FINALLY HE WRAPPED THE WIRE AROUND HIS HAND AND GAVE A REALLY HARD YANK. THE WIRE GUIDE WAS STRIPPED AT THE END OF THE TIP AS IT HAD APPARENTLY JAMMED IN THE ELEVATOR OF THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH THE NEW WIRE, IN THE LONG WIRE MODE, OF THE COOK FUSION QUATTRO EXTRACTION BALLOON. ACCORDING TO THE ADDITIONAL INFORMATION PROVIDED: A SMALL BLACK [PIECE OF] COATING WAS DISCOVERED WHEN THE PHYSICIAN ADVANCED THE BALLOON A SECOND TIME. THE PHYSICIAN WENT THROUGH THE ENDOSCOPE WITH THE PIECE OF COATING AND REMOVED IT FROM THE ENDOSCOPE OUTSIDE OF THE PATIENT. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7258983 ↗
• MalfunctionJan 26, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. AS REPORTED TO CUSTOMER RELATIONS, "DURING THE PROCEDURE, THE GUIDE WIRE WAS LOCKED ON THE COOK LOCKING DEVICE AND THE WIRE KEPT POPPING OUT. BECAUSE OF THIS, THE PHYSICIAN WAS LOSING ACCESS [TO THE DUCT]. THE DISTRICT MANAGER WAS PRESENT FOR THE CASE TO HELP THE PHYSICIAN AND STAFF. THE DISTRICT MANAGER WAS ABLE TO INDICATE TO THE PHYSICIAN A TECHNIQUE TO USE TO REMOVE THE SPHINCTEROTOME. THE PHYSICIAN USED A SWEEPING DEVICE (COOK EXTRACTION BALLOON) TO COMPLETE THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7221336 ↗
• MalfunctionDec 21, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THIS CASE WAS WITH A PATIENT WITH DOWN SYNDROME AND A LITTLE ABNORMAL ANATOMY. THE USER PLACED A WIRE GUIDE WITH A COOK FUSION OMNI SPHINCTEROTOME (FS-OMNI). CONTRAST WAS USED. WHEN SPLITTING, A LOOP ON THE WIRE LOCK FORMED ONCE. THEN, WHEN USING THE COOK FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-XL-A), IT HAPPENED ONCE AGAIN. CONTRAST USED AGAIN. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 12/11/17: WIRE GUIDE ACCESS TO THE COMMON BILE DUCT WAS LOST DURING THIS CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7139058 ↗
• MalfunctionAug 3, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. WHEN THE SPHINCTEROTOME WAS BEING PULLED OUT, THE WIRE GUIDE WAS COMING OUT WITH IT [THE SPHINCTEROTOME] AT THE WIRE LOCK. THEY WERE ABLE TO WORK IT BACK AND FORTH TO GET IN POSITION. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE COOK AREA REPRESENTATIVE ON 7/20/17: DUCTAL ACCESS WAS LOST AND I THINK IT IS IMPORTANT TO MENTION THAT THE SPHINCTEROTOME WAS ANOTHER MANUFACTURER'S DEVICE. I FEEL THAT THE ISSUE IS A COMPATIBILITY ISSUE WITH THIS PARTICULAR SPHINCTEROTOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6765183 ↗
• MalfunctionJun 5, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE HYDROPHILIC PORTION OF THE ACROBAT 2 WIRE GUIDE STRIPPED DUE TO THE POSSIBILITY OF THE WIRE GETTING CAUGHT ON THE ELEVATOR OF THE ERCP ENDOSCOPE. THE WIRE SLIGHTLY TOUCHED THE INSIDE OF THE ENDOSCOPE CHANNEL WHEN BARELY INSERTED INTO THE DUODENUM, DID NOT MAKE IT TO THE BILE DUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6612806 ↗