ClearView Uterine Manipulator UM700Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814247020017), received between Jan 14, 2020 and Sep 18, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024

  SMALL BLACK TIP CAME OFF FROM THE CLEARVIEW MANIPULATOR WHEN IT WAS INSERTED INTO THE VAGINA, TIP WAS LOCATED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20244951 ↗
• InjuryJul 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, THE CLEARVIEW UTERINE MANIPULATOR WAS USED IN A SURGICAL PROCEDURE.ON JUNE 25, 2024, THE PATIENT NOTIFIED HER PHYSICIAN THAT SMALL, PLIABLE, WHITE PARTICLES WERE COMING FROM HER VAGINA.ON JUNE 26, 2024, THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE AND PRESENTED SMALL, SOFT, RUBBERY WHITE PARTICLES IN A BAGGIE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19778948 ↗
• InjuryMar 1, 2023Use of Device Problem; Use of Device Problem

  IN THE CUSTOMER WORDS: " SPACER CAME OFF DURING THE SURGERY, BUT DOCTORS WERE NOT AWARE. SPACER WAS FOUND AFTER FINISHING THE SURGERY AND PICKED OUT THREE DAYS LATER." NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462778 ↗
• MalfunctionFeb 2, 2022Detachment of Device or Device Component

  CUSTOMER REPORTED "I AM E-MAILING WITH REGARDS TO YOUR CLEARVIEW UTERINE MANIPULATOR, WITH THE 7CM BLUNT TIP (REF: UM700). WE HAVE HAD AN EVENT OVER THE WEEKEND WITH REGARDS TO A PATIENT HAVING RETAINED A PART OF THE MANIPULATOR AND THEN THEY PASSED THIS. THE ITEM WAS THE SPACER THAT COMES SEPARATELY FROM THE MANIPULATOR, IN THE BOX."

  Patient problems: Insufficient Information

  MAUDE report 13426408 ↗
• MalfunctionJan 14, 2020Entrapment of Device; Detachment of Device or Device Component

  ON (B)(6) 2019 A PATIENT HAD AN ABDOMINAL MYOMECTOMY IN WHICH A CLEARVIEW UTERINE MANIPULATOR (REF#UM700) WAS USED. SOMETIME DURING CASE THE WHITE TIP OF THE UTERINE MANIPULATOR CAME OFF AND REMAINED INSIDE THE PATIENT. NO ONE NOTICED THAT THE TIP HAD COME OFF AND REMAINED IN THE PATIENT DURING SURGERY. IT WAS NOT UNTIL LATER IN THE DAY WHEN THE PATIENT WAS USING THE BATHROOM AND THE TIP WAS EXPELLED THAT THE REALIZATION OF THE RETAINED TIP WAS DISCOVERED. THE HAND PIECE WAS NOT SAVED. NOR WAS THE SERIAL NUMBER RECORDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9587744 ↗

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.