Hysteroscopic Fluid Management System Stand 7210165Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010529541), received between Apr 16, 2019 and Sep 3, 2020 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2020Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING HYSTEROSCOPIC MYOMECTOMY, THE SURGEON USED A COMBINATION OF INSTRUMENTS TO REMOVE MYOMA'S. BOVIE PENCIL AND TRUCLEAR DENSE SHAVER (WHICH WAS NOT DEFECTIVE. USED FOR RESECTION ONLY). LARGE PIECES WERE REMOVED. PATIENT HAD BLEEDING FROM WHERE THESE MYOMA PORTIONS WERE JOINED TO THE CERVIX. SURGEON SUTURED THE CERVIX TO STOP THE BLEEDING. THE BLOOD LOSS WAS NOTED TO BE 1 LITER. ALSO NOTED WAS THERE WAS MORE FLUID OUTPUT THAN THERE WAS FLUID INPUT. FLUID SCALE NUMBERS WERE NEGATIVE THROUGHOUT PROCEDURE. MANUAL COUNTS OF FLUID WERE PERFORMED. HEMOGLOBIN AND HEMATOCRICT COUNT WAS ORDERED, HEMOGLOBIN WAS ~ 13 (PRE-OPERATIVE WAS ~ 14). THE BOWEL OF THE PATIENT PERFORATED AND CURRENTLY IN COLOSTOMY BAG. THE PATIENT HAD 102 DEGREES OF FEVER DAY AFTER THE PROCEDURE, INSTRUCTED TO GO TO EMERGENCY ROOM BUT DID NOT COME IMMEDIATELY. THE FOLLOWING DAY, PATIENT WAS TAKEN TO OTHER HOSPITAL EMERGENCY ROOM AND FOUND TO BE IN SEPSIS SHOCK AND NOT PRODUCING URINE. THEY FREE THE FLUID IN THE ABDOMEN AND A PERFORATION SEEN IN THE SIGMOID. THE PATIENT WAS RELEASED TO EMERGENCY ROOM 1-2 DAYS LATER.

  Patient problems: Blood Loss; Bowel Perforation; Fever; No Code Available; Septic Shock

  MAUDE report 10490859 ↗
• MalfunctionJan 29, 2020Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE SCALE OFF HAD INACCURATE READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9641599 ↗
• MalfunctionJan 8, 2020Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S SCALE WAS NOT REGISTERING CORRECT VOLUME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9562198 ↗
• MalfunctionDec 12, 2019Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING TESTING, THE UNIT WAS NOT WORKING AND SHOWED LARGER DEFICIT WHEREIN WAS CONFIRMED BY DOING MANUAL COUNT. THE DEFICIT ON FIRST CASE WAS APPROXIMATELY 1100 CUBIC CENTIMETERS (CC) AND ON THE SECOND CASE WAS APPROXIMATELY 500 CC. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9459237 ↗
• MalfunctionOct 21, 2019Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY MYOMECTOMY, THE LEGACY FLUID MANAGEMENT SCALE WENT INTO AN EXTENDED ¿BAG MODE¿ FOR AP PROXIMATELY 7-8 MINUTES WHICH RESET TO AN INCORRECT DEFICIT READING. A MANUAL COUNT WAS PERFORMED AND THE FLUID DEFICIT LIMIT WAS REACHED. THE CASE WAS STOPPED DUE TO REACHING THE MAXIMUM FLUID DEFICIT, WHICH WAS CALCULATED BY PERFORMING A MANUAL COUNT. THERE WAS NO PATIENT INJURY. NO ADDITIONAL DETAILS ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215904 ↗
• MalfunctionSep 30, 2019Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING TESTING, THE DEVICE'S OUTFLOW ON THE SCALE WAS NOT MEASURING CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9135984 ↗
• MalfunctionAug 20, 2019Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING TESTING, THE DEVICE WAS NOT READING FLUID DEFICITS PROPERLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Information

  MAUDE report 8911486 ↗
• MalfunctionJun 5, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ACCORDING TO THE REPORTER, THE BOTTOM SCALE WAS NOT READING CORRECTLY.

  Patient problems: No Information

  MAUDE report 8671337 ↗
• MalfunctionApr 16, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ACCORDING TO THE REPORTER, DURING ANNUAL INSPECTION, THE UNIT WAS NOT MEASURING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8521009 ↗