ClearView Uterine Manipulator UM900Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814247020604), received between Dec 19, 2016 and May 26, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K940681); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2022Device Dislodged or Dislocated

  IN THE CUSTOMERS WORDS: "THANK YOU FOR RETURNING MY CALL EARLIER WITH REGARDS TO THE ABOVE. AS I MENTIONED THIS WOULD BE THE SECOND TIME THIS TYPE OF INCIDENT HAS HAPPENED ON MY WATCH WITHIN THE LAST 2/3 YEARS. THE INCIDENTS ARE IDENTICAL IN THAT THE SPACER WAS LEFT INSIDE THE VAGINA OF BOTH PATIENTS AFTER THE MANIPULATOR HAD BEEN REMOVED. THE ASSUMPTION IS THAT THE SPACER IS CLICKED INTO PLACE BUT MAY DISLODGE WITH MOVEMENT WHILST BEING USED THEREFORE POTENTIALLY LEFT BEHIND. BOTH PATIENT HAD TO GO TO A&E TO HAVE THE FOREIGN BODY REMOVED. UNFORTUNATELY I DO NOT HAVE ANY LOT NUMBERS FOR ANY OF THE PRODUCTS AS THIS IS ONLY NOTICED A FEW DAYS AFTER THE PROCEDURE THEREFORE PRODUCT WILL ALREADY HAVE BEEN THROWN AWAY. THE 1ST I ENCOUNTERED THIS WAS AT (B)(6) HOSPITAL AND THE PRODUCT WAS EITHER THE UM700 OR UM900. THIS TIME I AM WORKING AT (B)(6) HOSPITAL AND THE PRODUCT USED WAS UM900 AS WE ONLY ORDER THE ONE PRODUCT. SINCE WE HAD THIS INCIDENT I WOULD LIKE TO REQUEST SOME TRAINING FOR MY STAFF AS EVIDENCE FOR THE PATIENT THAT SOMETHING HAS BEEN DONE TO PREVENT THIS FROM HAPPENING SOMEONE ELSE."

  Patient problems: Foreign Body In Patient

  MAUDE report 14518226 ↗
• InjuryDec 19, 2016Overfill; Human Factors Issue; Overfill; Human Factors Issue

  DURING A SURGERY THE TUBES SHOULD BE FLUSHED TO EVALUATE IF ONE OR TWO TUBES SHOULD BE REMOVED. THE CLEAR VIEW IS INSERTED INTO THE UTERUS AND TO KEEP IT THERE 2-3 ML SALTED WATER IS INFUSED TO FILL A SMALL BALLOON. THERE ARE TWO TUBES ONE TO FILL THE BALLOON AND ONE FOR INJECTION OF CONTRAST FLUID. DURING THE OPERATION THE CONTRAST FLUID WAS CONNECTED TO THE WRONG TUBE AND THE BALLOON INSIDE THE UTERUS WAS INFLATED FURTHER AND THE PRESSURE IN THE UTERUS BECAME SO HIGH, THAT THE UTERUS BLEW IN THE TOP OF UTERUS. THE CONSEQUENCE OF THE INCIDENCE IS THAT THE PATIENCE IS NOT RECOMMENDED TO PERFORM A VAGINAL BIRTH AS THE RISK OF RUPTURE OF UTERUS IS HIGH DURING BIRTH. BESIDES THAT IT IS NOT RECOMMENDED TO GET PREGNANT FOR THE NEXT 3 MONTHS WHICH IS A BURDEN AS THE PATIENT ALREADY IS A FERTILITY PATIENT.

  Patient problems: Uterine Perforation

  MAUDE report 6186487 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K940681. One submission often covers many models, so check the product and lot details in each record.

• Z-1817-2008 · May 12, 2008 · Terminated
  ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.
• Z-1818-2008 · May 12, 2008 · Terminated
  ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.