Novy G17558Recalls & reported problems
Cook Incorporated · Modified Novy Cornual Cannulation Set · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002175587), received between Oct 17, 2019 and Aug 18, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (3 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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping3
- Peeled/Delaminated2
- Break1
- Fracture1
- Material Discolored1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient2
- No Code Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Break
It was reported that the distal end of the inner catheter from a Modified Novy Cornual Cannulation Set broke upon entering the opening of the fallopian tube during a hysteroscopy procedure.The edges of the fractured catheter wall exhibited elongation, thinning, and curling. Photos of the broken device were provided. All device fragments were successfully retrieved. The procedure was completed using by using another same-like device. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304607 ↗MalfunctionNov 22, 2024Material Discolored; Device Contaminated During Manufacture or Shipping; Material Discolored; Device Contaminated During Manufacture or Shipping
AS REPORTED, THE MODIFIED NOVY CORNUAL CANNULATION SET POUCH WAS VISIBLY YELLOW (FOREIGN MATTER IS IDENTIFIED WITHIN THE DEVICE OR PACKAGING), THIS ISSUE WAS DISCOVERED PRIOR TO PACKAGE BEING OPENED AND IT WAS NOT USED ON A PATIENT. THE INITIAL REPORTER BELIEVED THE DEVICE MAY HAVE BEEN CONTAMINATED DUE TO YELLOW POUCH AND OPTED NOT TO USE THE DEVICE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20757577 ↗MalfunctionMar 14, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, BLACK FOREIGN MATTER WAS FOUND IN AN UNOPENED 'MODIFIED NOVY CORNUAL CANNULATION SET' PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18908843 ↗MalfunctionJan 10, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, PRIOR TO USE, A HAIR WAS FOUND INSIDE THE PACKAGING OF A MODIFIED NOVY CORNUAL CANNULATION SET. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18489295 ↗MalfunctionApr 13, 2021Peeled/Delaminated; Peeled/Delaminated
THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11655348 ↗InjurySep 4, 2020Peeled/Delaminated; Peeled/Delaminated
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Code Available
MAUDE report 10496600 ↗MalfunctionJun 17, 2020Material Separation; Material Separation
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10164032 ↗MalfunctionOct 17, 2019Fracture; Fracture
NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 17OCT2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9204253 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.