ClearView Total Uterine Manipulator UM750Recalls & reported problems
Clinical Innovations, LLC · ClearView Total Uterine Manipulator, regular tip (7cm) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814247020499), received between May 13, 2019 and May 16, 2019 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Component Missing2
- Manufacturing, Packaging or Shipping Problem1
- Structural Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Consequences Or Impact To Patient4
- Injury1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2019Therapeutic or Diagnostic Output Failure
BEFORE USE, THERE IS NO GROOVE FOR FIXING THE COLPOTOMY CUP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8617037 ↗MalfunctionMay 16, 2019Manufacturing, Packaging or Shipping Problem
NO GROOVE TO ATTACH THE COLPOTOMY CUP. OUR QA PEOPLE CHECKED ALL CLEARVIEW TOTAL DEVICES AND FOUND 1 THAT HAD EXACTLY THE SAME PROBLEM THAT WE REPORTED LAST WEEK. THIS DEVICE WAS STORED IN THE WAREHOUSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8616997 ↗MalfunctionMay 16, 2019Component Missing
NO GROOVE TO ATTACH THE COLPOTOMY CUP. OUR QA PEOPLE CHECKED ALL CLEARVIEW TOTAL DEVICES AND FOUND 1 THAT HAD EXACTLY THE SAME PROBLEM THAT WE REPORTED LAST WEEK. THIS DEVICE WAS STORED IN THE WAREHOUSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8616956 ↗MalfunctionMay 16, 2019Structural Problem
NO GROOVE TO ATTACH THE COLPOTOMY CUP. OUR QA PEOPLE CHECKED ALL CLEARVIEW TOTAL DEVICES AND FOUND 1 THAT HAD EXACTLY THE SAME PROBLEM THAT WE REPORTED LAST WEEK. THIS DEVICE WAS STORED IN THE WAREHOUSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8616917 ↗InjuryMay 13, 2019Component Missing; Component Missing
THIS IS A REPORT ON A HEALTH INJURY CAUSED BY YOUR DEFECTIVE CLEARVIEW TOTAL WITH NO NOTCH (A GROOVE TO FIX THE COLPOTOMY CUP TIGHTLY). THE DOCTOR TRIED TO INSERT THE DEVICE WITH THE CUP BEING INSUFFICIENTLY FIXED INTO A PATIENT AND HURT HER VAGINAL PORTION OF CERVIX DUE TO NO SULCUS FIXATION APPLIED.
Patient problems: Injury
MAUDE report 8606170 ↗
Other Cannula, Manipulator/Injector, Uterine devices
- VCARE 60-6085-201AConmed Corporation · Cannula, manipulator/injector, uterine198 reports
- Cook G17147Cook Incorporated · Cannula, manipulator/injector, uterine68 reports
- Mckesson 11-19611Mckesson Medical-Surgical Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Catheter with Integrated Stylet • 5 French 61-3005Coopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Elliptosphere™ Catheter with Integrated Stylet 61-4005SCoopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- H/S Elliptosphere™ Catheter • 5 French 61-4005Coopersurgical, Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- Mckesson 11-19610Mckesson Medical-Surgical Inc. · Cannula, Manipulator/Injector, Uterine1 recall0 reports
- VCARE 60-6085-202AConmed Corporation · Cannula, manipulator/injector, uterine46 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page