Hysteroscopic Fluid Management 7210164Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010529534), received between Dec 9, 2019 and Mar 30, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (6 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2021Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S OUTPUT MEASUREMENT WAS TOO HIGH. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588873 ↗
• MalfunctionOct 15, 2020Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY (&) POLYPECTOMY, THE FLUID MANAGEMENT SYSTEM UNIT WITH PRESSURE WAS SET AT 80, SALINE SOLUTION WAS USED AS DISTENTION MEDIUM (FLUID BAG SIZE 3000ML) ONLY 1 BAG IN QUANTITY. BUT WHEN IT WAS END OF PROCEDURE IT DISPLAYED A DEFICIT 800ML. MANUAL MEASUREMENT WAS DONE WITH FLUID DEFICIT ONLY OF 200ML AND TOTAL INFLOW FLUID USED OF 600ML WITH LAST REMAINING FLUID FROM SALINE BAG OF 2400ML. IT WAS NOTED THAT THE FLUID MANAGEMENT SYSTEM UNIT WAS RESET TO ZERO AFTER PRIMING; NO FLUID WAS LEFT UNDER THE BUTTOCK OF PATIENT'S DRAPE NOR FLUID SPILL ON THE FLOOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10683318 ↗
• MalfunctionAug 24, 2020Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY WITH POLYPECTOMY, THE FLUID MANAGEMENT SCALE WAS OFF, SYSTEM WAS LISTING DEFICIT AS VERY HIGH NUMBER WHEN ONLY A FEW HUNDRED ML WERE ENTERING CAVITY AND HAD TO COMPLETE PROCEDURE WITH MANUAL COUNT OF FLUID AT END. THEY PERFORMED 3 CHECKS AS LISTED IN THE INSTRUCTION FOR USE BUT THE MACHINE DID NOT WORKED PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10446027 ↗
• MalfunctionFeb 3, 2020Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING HYSTEROSCOPIC RESECTION WHILE INSIDE THE UTERINE CAVITY DURING MYOMETRIAL PENETRATION, THE SURGEON NOTICED AN INCREASED IN THE FLUID DEFICIT LEVEL. SURGEON SAID THE DEFICIT WAS 1000CC AT ONE POINT. AFTER 5 MINUTES, DEFICIT WAS 5000CC. SURGEON SAID THERE WERE NO ALARMS OR BEEPS. MACHINE WAS CHECKED LATER AND FOUND TO HAVE PROPER FLUID DEFICIT ALARMING FUNCTION. IT WAS SUGGESTED BY SURGEON TO INCREASED VOLUME OF ALARM. NURSE DID NOT COMMUNICATE NOR REPORT THE DEFICIT DURING THIS 5 MINUTES INTERVAL. PATIENT WAS GIVEN LASIX INTRAVENOUSLY. SURGEON SAID PATIENT URINE WAS 4000CC FOLLOWING LASIX. THERE WAS NO CHANGE IN PATIENT ELECTROLYTES AND WAS DISCHARGED. ALL TISSUE HAD BEEN RESECTED. PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9660647 ↗
• MalfunctionDec 12, 2019Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING TESTING, THE FLUID MANAGEMENT SYSTEM WAS NOT WORKING AND WAS SHOWING A LARGER DEFICIT. THE DEFICIT WAS OFF AND CONFIRMED BY DOING A MANUAL COUNT. 1ST CASE OFF BY APPROXIMATELY 1100CC AND 2ND CASE OFF BY APPROXIMATELY 500CC. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9459772 ↗
• MalfunctionDec 9, 2019Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE UNIT WAS NOT MEASURING ACCURATELY.

  Patient problems: No Information

  MAUDE report 9438850 ↗