Acrobat G34266Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00827002342668), received between Mar 21, 2016 and May 22, 2025 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (44 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. DURING THE PROCEDURE THE PHYSICIAN DETECTED THE COATING OF THE WIRE GUIDE PEEL OFF [COATING DAMAGE], THEN RETRACTED THE WIRE GUIDE AND CHANGED TO A ZEBRA WIRE GUIDE TO COMPLETE THE PROCEDURE [LOSS OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22072131 ↗
• MalfunctionMay 8, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. IT WAS REPORTED THAT THE PHYSICIAN DETECTED THE COATING OF THE WIRE GUIDE PEEL OFF AND CHANGED TO ANOTHER ONE OF THE SAME DEVICES TO CONTINUE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21987790 ↗
• MalfunctionApr 17, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. IT WAS REPORTED THAT THE COVERING PEELS/DETACHES FROM WIRE GUIDE DURING STENT IMPLANTATION, REPLACEMENT OF WIRE GUIDE [LOSS OF WIRE GUIDE ACCESS] AND CONTINUATION OF CANNULATION AND IMPLANTATION [WAS REQUIRED]. 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 21858361 ↗
• MalfunctionApr 3, 2025Peeled/Delaminated; Peeled/Delaminated

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. IT WAS REPORTED THAT THE PHYSICIAN OPENED THE PACKAGE AND TOOK OUT THE DEVICE AND FOUND THE HYDROPHILIC COATING BROKEN AND OFF. NOT USED ON PATIENT. AN IMAGE SHOWING THE WIRE GUIDE COATING DAMAGE WAS PROVIDED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769973 ↗
• MalfunctionNov 25, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE USER DETECTED THE WIRE GUIDE COATING PEELED OFF DURING PROCEDURE UNDER ENDOSCOPIC VIEW. THE USER CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. THE PHOTO PROVIDED DEPICTS THE COATING DAMAGE BETWEEN 20 AND 21 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 9371320 ↗
• MalfunctionNov 19, 2019Peeled/Delaminated; Peeled/Delaminated

  PRIOR TO A ENDOSCOPIC PROCEDURE, THE PHYSICIAN OPENED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE FROM THE PACKAGING. IT WAS FOUND OUT THAT THE COATING OF THE WIRE GUIDE PEELED OFF. THE PHYSICIAN CHANGED TO ANOTHER COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE TO COMPLETE THE PROCEDURE. BASED ON THE PHOTO PROVIDED, THE DAMAGE APPEARS TO BE AROUND 20-25 CENTIMETERS (CM) THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9341674 ↗
• MalfunctionNov 4, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE USER FOUND OUT THE COATING OF WIRE GUIDE PEELED OFF DURING ERCP 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 9273099 ↗
• MalfunctionOct 18, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE USER FOUND OUT THE SURFACE OF WIRE GUIDE PEELED OFF DURING 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 9208302 ↗
• MalfunctionOct 11, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) ACROBAT CALIBRATED TIP WIRE GUIDES. THE USER FOUND OUT THE SURFACE OF WIRE GUIDES PEELED OFF DURING 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 9181995 ↗
• MalfunctionAug 7, 2019Peeled/Delaminated; Peeled/Delaminated

  THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA ON (B)(6) 2019: "DURING A STONE REMOVAL PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE USER ADVANCED THE WIRE GUIDE THROUGH THE ENDOSCOPE TO BE USED WITH A COOK TRI-EX MULTIPLE SIZE EXTRACTION BALLOON (TXR-8.5-12-15-A) TO REMOVE THE STONE. THE USER FOUND OUT THE WIRE GUIDE WAS KINKED WHILE REMOVING THE WIRE GUIDE FROM THE PATIENT. THE USER COULD NOT REMOVE THE WIRE GUIDE FROM THE PATIENT BECAUSE OF THE KINK ISSUE. THE USER RETRACTED THE ENDOSCOPE ALONG WITH WIRE GUIDE AND EXTRACTION BALLOON ALL TOGETHER FROM THE PATIENT [LOST WIRE GUIDE ACCESS]. WHILE RETRACTING THE ENDOSCOPE FROM THE PATIENT, THE HYDROPHILIC COATING OF THE WIRE GUIDE PEELED OFF. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED." ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 REGARDING THE PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8871554 ↗
• MalfunctionJul 2, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE USER FOUND OUT THAT THE SURFACE OF THE WIRE GUIDE PEELED OFF DURING 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 8754205 ↗
• MalfunctionMay 30, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING A STONE REMOVAL PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE COATING OF THE WIRE GUIDE PEELED OFF DURING ADVANCEMENT OF A BALLOON DEVICE FROM ANOTHER MANUFACTURER. THE USER CHANGED TO A WIRE GUIDE FROM ANOTHER MANUFACTURER IMMEDIATELY AND COMPLETED THE PROCEDURE. THE PHOTOS PROVIDED FROM THE CUSTOMER INDICATED THAT THE COATING DAMAGE WAS WITHIN THE FIRST 25 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 8656121 ↗
• MalfunctionMay 30, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING A STONE REMOVAL PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE COATING OF THE WIRE GUIDE PEELED OFF DURING ADVANCEMENT OF A COOK FUSION EXTRACTION BALLOON. THE USER CHANGED TO A WIRE GUIDE FROM ANOTHER MANUFACTURER IMMEDIATELY AND COMPLETED THE PROCEDURE. THE PHOTOS PROVIDED FROM THE CUSTOMER INDICATED THAT THE BARE CORE WIRE OF THE WIRE GUIDE IS EXPOSED DISTAL TO THE 22 CM SILVER MARKING. 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 8656118 ↗
• MalfunctionApr 11, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING A PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT CALIBRATED WIRE GUIDE. PER THE PHOTO PROVIDED, THE DEVICE APPEARED TO HAVE COATING DAMAGE. THE COATING OF THE WIRE GUIDE PEELED OFF AT THE PATIENT END DURING 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 8506067 ↗
• MalfunctionMar 18, 2019Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE WIRE GUIDE AND A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME (TRI-25M-P) WERE ADVANCED TO THE DESIRED POSITION (BILE DUCT), AND AFTER ONE (1) MINUTE THE SURFACE OF WIRE GUIDE PEELED OFF [COATING DAMAGE]. THE USER RETRACTED THE WIRE GUIDE AND SPHINCTEROTOME TOGETHER [LOSS OF WIRE GUIDE ACCESS] FROM THE PATIENT AND USED ANOTHER OF THE SAME PRODUCT TO FINISH 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 8430032 ↗
• MalfunctionFeb 15, 2019Entrapment of Device; Peeled/Delaminated; Entrapment of Device; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. THE WIRE GUIDE WAS ADVANCED TO THE DESIRED POSITION AND WAS READY TO PLACE THE STENT. THE USER RELEASED THE STENT AND MEANWHILE WITHDREW THE WIRE GUIDE BUT THERE WAS SLIGHT RESISTANCE. THE STENT WAS PLACED IN THE DESIRED POSITION, THE USER TRIED TO WITHDRAW THE WIRE GUIDE, BUT FOUND THAT THEY COULD NOT WITHDRAW THE WHOLE WIRE GUIDE. THE USER WITHDREW THE WIRE GUIDE ALONG WITH THE STENT FROM THE PATIENT, FOUND OUT [THAT] THE SURFACE OF THE WIRE GUIDE PEELED OFF, AND WAS TANGLED WITH THE STENT. THE USER CHANGED TO ANOTHER OF THE SAME WIRE GUIDE AND STENT 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 8343589 ↗
• MalfunctionFeb 12, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE USER INTRODUCED THE WIRE GUIDE REPEATEDLY INTO THE SPHINCTEROTOMY SHEATH. THE COATING OF WIRE GUIDE CRACKED [COATING DAMAGED]. 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 8331040 ↗
• MalfunctionJan 18, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE DEVICE WAS ADVANCED TO THE DESIRED POSITION, BUT THE USER FELT OBVIOUS RESISTANCE DURING USE. THE USER RETRACTED THE DEVICE FROM THE PATIENT AND FOUND OUT THAT THE SURFACE IS PARTIALLY PEELED OFF FROM THE WIRE GUIDE [COATING DAMAGE]. THE USER CHECKED AND CONFIRMED THERE WAS NO SURFACE [COATING] OF THE WIRE GUIDE LEFT IN THE PATIENT. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE TO CONTINUE AND FINISH 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 8262551 ↗
• MalfunctionJan 18, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE DEVICE WAS ADVANCED TO DESIRED POSITION, BUT THE USER FELT OBVIOUS RESISTANCE DURING USE. THE USER RETRACTED THE DEVICE FROM THE PATIENT AND FOUND OUT THE SURFACE WAS PARTIALLY PEELED OFF FROM THE WIRE GUIDE [COATING DAMAGE]. THE USER CHECKED AND CONFIRMED THERE WAS NO SURFACE [COATING] OF WIRE GUIDE WAS LEFT IN THE PATIENT. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE TO CONTINUE AND FINISH 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 8262531 ↗
• MalfunctionDec 27, 2018Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. THE USER FOUND OUT THROUGH ENDOSCOPY THAT THE SURFACE OF THE TIP OF WIRE GUIDE PEELED OFF [COATING DAMAGE] DURING THE PROCEDURE. THE USER WITHDREW THE DEVICE [LOST WIRE GUIDE ACCESS] FROM THE ENDOSCOPE AND PATIENT AND CONFIRMED NO SURFACE WAS LEFT IN PATIENT. THE USER USED ANOTHER [OF THE] SAME DEVICE TO CONTINUE THE PROCEDURE AND FINISHED. 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 8199812 ↗
• MalfunctionNov 15, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PHYSICIAN USED A COOK ACROBAT CALBRIATED TIP WIRE GUIDE. THE COATING OF THE WIRE STRIPPED OFF THE WIRE. THEY NOTICED IT AS THEY PASSED THE COOK EVOLUTION BILIARY STENT OVER THE WIRE GUIDE. 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 8073489 ↗
• MalfunctionNov 12, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. AFTER SPHINCTEROTOMY, THE PHYSICIAN TRIED TO EXCHANGE TO AN EXTRACTION BALLOON BUT THE ASSISTANT FELT MUCH RESISTANCE IN ADVANCING THE WIRE GUIDE. THE PHYSICIAN TRIED TO LOCK THE WIRE GUIDE WITH THE SCOPE V SYSTEM[ELEVATOR] BUT IT DID NOT WORK AS WELL. THEY THEN REMOVED THE ACROBAT WIRE GUIDE AND USED ANOTHER MANUFACTURER'S WIRE GUIDE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 18-OCT-218 AND IT WAS DETERMINED THAT THERE WAS COATING DAMAGE AT THE DISTAL 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 8060107 ↗
• MalfunctionApr 27, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE COVERING [OF THE WIRE GUIDE] PEELED [AND] DETACHED FROM THE WIRE GUIDE. IT WAS DETECTED DURING THE PROCEDURE. THE DEVICE WAS EVALUATED ON 04/12/2018 AND IT WAS OBSERVED THAT A SMALL 0.3 CM PIECE OF WIRE GUIDE COATING WAS HANGING OFF OF THE WIRE GUIDE, AND THE WIRE GUIDE COATING HAD FOLDED OVER ONTO ITSELF AT LEAST ONCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7469083 ↗
• MalfunctionApr 24, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. DURING THE EXCHANGE, THE OPERATOR FELT OBVIOUS RESISTANCE AND CHECKED FROM THE ENDOSCOPE AND FOUND THAT THE COVERING [OF THE WIRE GUIDE] HAD PEELED AND DETACHED. THE DEVICE WAS EVALUATED ON 04/12/2018 AND IT WAS OBSERVED THAT THE WIRE GUIDE COATING HAD FOLDED OVER ITSELF EXPOSING THE BARE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7455747 ↗
• MalfunctionFeb 26, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE WIRE GUIDE WAS ADVANCED BY A COOK FUSION OMNI-TOME SPHINCTEROTOME (FS-OMNI) INTO THE COMMON BILE DUCT SUCCESSFULLY. THE OPERATOR DETECTED THE OUTER SURFACE OF WIRE GUIDE IS DETACHED AT 23 CM FROM DISTAL END WHILE RETRIEVING THE FS-OMNI SPHINCTEROTOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7296188 ↗