NA Uterine ManipulatorRecalls & reported problems
C R I · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00852073002517), received between Apr 21, 2017 and Apr 21, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2017Material Fragmentation
DESCRIPTION FROM THE USER- FACILITY: "THE USER FACILITY REPORTED ON (B)(6) 2016 THAT THE PATIENT'S SPOUSE CALLED TO REPORT THAT THE PATIENT FELT A PLASTIC PIECE IN VAGINA. REPORTED A FOUR INCH SMALL PLASTIC PIECE WAS REMOVED. SURGEON WAS CALLED AND HE CONTACTED THE PATIENT. SPOKE WITH OR AND SAID IT WAS MOST LIKELY FROM THE HUMI (SIC) UTERINE MANIPULATOR. SPOKE WITH PATIENT . MET THEM AT SURGEON'S OFFICE, AND THEY PRESENTED THE PIECE WHICH HAS BEEN REMOVED. THE PIECE WAS A SEGMENT OF THE UTERINE MANIPULATOR. PATIENT INSTRUCTED TO OBSERVE FOR ANY OTHER CHANGES, SIGNS, OR SYMPTOMS AND TO CALL WITH ANY QUESTIONS AND CONCERNS. THE ORIGINAL INTENDED PROCEDURE WAS ROBOTIC SURGERY FOR OVARIAN CYST."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6513083 ↗
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.
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