HysteroLux™ Fluid Management System Scale PS304Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04056702006273), received between May 28, 2020 and Sep 5, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K173489); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "ACCORDING TO THE REPORTER, THE UNIT HAD DEFICIT CALCULATION ISSUES. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION 1.HOW WAS THE ISSUE NOTICED? DURING SET UP. 2.COULD WE PLEASE GET MORE INFORMATION, IF THERE WAS ISSUE WITH LOW DEFICIT OR HIGHER DEFICIT? LOW DEFICIT. AS THE COMPLAINT IS REGARDING THE DEFICIT, WHICH COULD BE RELATED TO AN ISSUE WITH SCALE. 3.COULD YOU PLEASE PROVIDE SN OF THE SCALE AND SEND BACK ALSO THE SCALE BACK AS WELL? REP SENT IT OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20143351 ↗
• InjurySep 18, 2020Incorrect, Inadequate or Imprecise Result or Readings

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: FROM: (B)(6), (B)(6) 2020. "ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY, THERE WAS A DEFI-CIT READ 1800 AND DROPPED RAPIDLY TO 0 FOR NO APPARENT REASON. A SMALL AMOUNT OF FLUID COMING FROM UNDER BUTTOCKS DRAPE, THAT WAS BEING SUCTIONED TO THE CANISTERS IN THE STAND WAS NOTED. BUT NOT ENOUGH TO CAUSE A LARGE CHANGE IN DEFICIT. THE SYSTEM WERE RE-PRIMED WITH NEW TUBING AFTER THEY NOTICED THE QUICK AND UNWAR-RANTED CHANGE IN DEFICIT. THEY WERE UNABLE TO FINISH THE CASE AND NEEDED TO BRING BACK THE PATIENT TO REMOVE THE REST OF THE TISSUE DUE TO DEFICIT INACCURACY. ANOTHER HYSTEROSCOPY WAS PERFORMED." FROM: (B)(6), (B)(6) 2020. "AT THIS POINT THE COMPLAINT IS CLOSED AS A NO SAMPLE ON OUR SIDE. THE COMMUNICATIONS TASK IS CLOSED AND WE HAVE NOT RECEIVED THE PRODUCT BACK. WE HAVE REQUESTED IT TO COME BACK BUT IT HAS NOT BEEN RECEIVED. IF IT IS RECEIVED WE WILL REOPEN THE COMPLAINT AND PROCESS THE UNIT. IT IS NOT TAGGED AS STILL IN USE AS WE WERE NOT ABLE TO VERIFY THAT, AND WE HAVE NO EVIDENCE THAT IT WAS SENT FROM THE CUSTOMER, AT THIS POINT."

  Patient problems: Insufficient Information

  MAUDE report 10552465 ↗
• InjuryMay 28, 2020Fluid/Blood Leak; Self-Activation or Keying

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "ACCORDING TO THE REPORTER, DURING A HYSTEROSCOPY, THE MACHINE WAS WORKING NORMALLY AND THEN SWITCHED TO DIAGNOSTIC MODE IN THE MIDDLE OF THE CASE. SINCE THERE WERE NO ALARMS OF HIGH DEFICIT, THE UNIT KEPT GOING AND THEY NOTICED BY DOING MANUAL COUNT (B)(4) WAS MISSING AND PRESUMED TO BE INSIDE THE BODY. AFTER REBOOTING THE MACHINE MANY TIMES, THE UNIT WOULD WORK AND MOVED TO DIAGNOSTIC MODE AND THEN THEY WOULD GET A SCALES DEFECTIVE SAYING. THE SCALE TEST WAS STILL 0. THE SURGICAL TIME EXTENDED 30 MINUTES AND PROCEDURE WAS ABORTED. THE (B)(4) FLUID WAS NOT REMOVED AND WAS ABSORBED TO THE BLOOD STREAM. THE PATIENT HAD AN EXTENDED 2-NIGHT STAY HOSPITALIZATION AND WAS DOING WELL. "

  Patient problems: Foreign Body In Patient

  MAUDE report 10095937 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173489. One submission often covers many models, so check the product and lot details in each record.

• Z-2561-2021 · Jun 18, 2021 · Open, Classified
  Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000