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Kronner Manipujector 6003Recalls & reported problems

Coopersurgical, Inc. · Uterine manipulator · Class 2

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 00888937015805), received between Dec 23, 2019 and Dec 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Entrapment of Device1

Patient problems

  • Abdominal Pain1
  • Adhesion(s)1
  • Cyst(s)1
  • Device Embedded In Tissue or Plaque1
  • Nausea1
  • Urinary Frequency / Polyuria1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 23, 2019Break; Entrapment of Device

    REPORT STATED: "DURING THE (B)(6) 2017 SURGERY, SIGNIFICANT INJURIES WERE OBSERVED AS A RESULT OF THE FOREIGN BODY, INCLUDING BUT NOT LIMITED TO SIGNIFICANT ADHESIONS AND CYSTS COVERING THE AREA. PATIENT HAS REQUIRED ADDITIONAL MEDICAL CARE AND TREATMENT, AS WELL AS ADDITIONAL SURGERY, TO ALLEVIATE AND MITIGATE THE PAIN AND INJURY". 6003 KRONNER MANIPUJECTOR BOX (B)(4).

    Patient problems: Abdominal Pain; Adhesion(s); Cyst(s); Device Embedded In Tissue or Plaque; Nausea; Urinary Frequency / Polyuria

    MAUDE report 9512218 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.