Cook G08045Recalls & reported problems
Cook Incorporated · Cook Endoscopic Cholangiography Set · Class 1
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002080454), received between Jul 21, 2017 and Apr 24, 2023 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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
Device problems
- Device Contaminated During Manufacture or Shipping4
- Device Contamination with Chemical or Other Material4
- Delivered as Unsterile Product1
- Unsealed Device Packaging1
Patient problems
- No Patient Involvement8
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16798322 ↗MalfunctionAug 27, 2021Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THE PACKAGING OF A MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET HAD A MISSING SEAL "ON THE UNDERSIDE". THIS WAS NOTICED DURING INITIAL INSPECTION AND PRIOR TO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12377381 ↗MalfunctionOct 31, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9259967 ↗MalfunctionJun 7, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 8678054 ↗MalfunctionDec 27, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED FOREIGN MATTER, PIECE OF HAIR, WAS FOUND IN THE SEALED STERILE PACKAGE OF A MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET DURING INCOMING INSPECTION. THE DEVICE DID NOT MAKE PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8200107 ↗MalfunctionDec 27, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 8200089 ↗MalfunctionJan 17, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE INTERNATIONAL DISTRIBUTER REPORTED THAT THERE WAS A HAIR INSIDE THE PRIMARY PACKAGE OF THE MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET. THIS WAS DISCOVERED PRIOR TO THE USE OF THE PRODUCT AND NO PATIENT CONTACT OCCURRED; ACCORDINGLY, NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.
Patient problems: No Patient Involvement
MAUDE report 7201832 ↗MalfunctionOct 12, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING AN PRE-USE INSPECTION OF THE MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET, AN UNIDENTIFIED HAIR WAS DISCOVERED IN THE PRIMARY PACKAGE. THE CUSTOMER CONFIRMED THAT THE DEVICE NEVER MADE CONTACT WITH ANY PATIENT; ACCORDINGLY, NO ADVERSE EVENTS OCCURRED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.
Patient problems: No Patient Involvement
MAUDE report 6944103 ↗MalfunctionOct 5, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING AN PRE-USE INSPECTION OF THE MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET, AN UNIDENTIFIED PARTICLE WAS DISCOVERED IN THE PRIMARY PACKAGE. THE CUSTOMER CONFIRMED THAT THE DEVICE NEVER MADE CONTACT WITH ANY PATIENT; ACCORDINGLY, NO ADVERSE EVENTS OCCURRED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.
Patient problems: No Patient Involvement
MAUDE report 6916919 ↗MalfunctionJul 21, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
INTERNATIONAL CUSTOMER REPORTED FINDING A HAIR INSIDE THE DEVICE PRIMARY PACKAGE. THE OBSERVATION WAS MADE DURING INCOMING PRODUCT INSPECTION. THERE WAS NO PATIENT CONTACT, ACCORDINGLY THERE ARE NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 6731538 ↗
Other CATHETER, CHOLANGIOGRAPHY devices
- PVC Thoracic Catheters 15028Atrium Medical Corporation · Catheter, Cholangiography1 recall0 reports
- PVC Thoracic Catheters 8032Atrium Medical Corporation · Catheter, Cholangiography6 reports
- RX ERCP Cannula M00545780Boston Scientific Corporation · CATHETER, CHOLANGIOGRAPHY3 reports
- Fanelli G12950Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
- Reddick Scoop Tip Cholangiogram Catheter e2401-51Lemaitre Vascular, Inc. · Catheter, Cholangiography2 reports
- RX ERCP Cannula M00545770Boston Scientific Corporation · CATHETER, CHOLANGIOGRAPHY2 reports
- Cook G02847Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
- Cook G03196Cook Incorporated · CATHETER, CHOLANGIOGRAPHY2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.