Cook G22143Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002221437), received between Sep 30, 2016 and Apr 12, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2019Use of Device Problem; Failure to Align; Use of Device Problem; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME. FOR ERCP CANNULATION AND ENDOSCOPIC SPHINCTEROTOMY (EST), THE PHYSICIAN INSERTED A BILLROTH II [SPHINCTEROTOME] INTO THE ENDOSCOPE AND TRIED TO ACCESS TO THE AMPULLA. HOWEVER, THE DIRECTION OF THE TIP WAS IN THE OPPOSITE DIRECTION [INCORRECT CUTTING WIRE ORIENTATION], THE ORIENTATION WAS "NOT GOOD". HE COULD NOT ACCESS THE AMPULLA AND USED A NEW ONE [OF THE SAME TYPE] FOR CANNULATION. 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 8511430 ↗
• MalfunctionAug 3, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME. FOR ERCP CANNULATION AND ENDOSCOPIC SPHINCTEROTOMY, THE PHYSICIAN INSERTED THE BILLROTH II INTO THE ENDOSCOPE AND TRIED TO ACCESS TO THE AMPULLA. HOWEVER, THE DIRECTION OF THE TIP WAS IN THE OPPOSITE DIRECTION AND ORIENTATION WAS NOT GOOD [INCORRECT CUTTING WIRE ORIENTATION]. SO THE PHYSICIAN COULD NOT ACCESS THE AMPULLA. HE USED A NEW ONE [DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME] FOR CANNULATION. 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 7747122 ↗
• MalfunctionOct 5, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME (PTG-20-6-BII-NG). THE CUTTING WIRE ON THE PTG-20-6-BII-NG IS DESIGNED TO ORIENTATE IN THE POSITION REQUIRED FOR PATIENTS WITH ALTERED ANATOMY SUCH AS IN THIS PROCEDURE. IN THIS CASE, THE CUTTING WIRE WAS IN THE INCORRECT [CUTTING WIRE] ORIENTATION REQUIRED FOR THIS PATIENT¿S ANATOMY. THE PHYSICIAN COMPLETED THE PROCEDURE INSTEAD BY GAINING ACCESS TO THE BILIARY SYSTEM BY USING THE ROTATING FEATURE ON THE FUSION OMNI-TOME SPHINCTEROTOME (FS-OMNI) AND PERFORMED THE SPHINCTEROTOMY WITH THE COOK FUSION TRIPLE LUMEN NEEDLE KNIFE (FS-PRECUT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6917204 ↗
• MalfunctionSep 30, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOMES. THE CUTTING WIRE POINTED IN THE WRONG DIRECTION, AT THE 12 O'CLOCK POSITION. THE CUTTING WIRE OF THE SPHINCTEROTOME WAS ORIENTED TO THE WRONG SIDE, OPPOSITE TO THE CORRECT SIDE [FOR BILLROTH II ANATOMY].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5990197 ↗