ENDOMAT 20330320-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551066423), received between Oct 11, 2017 and Nov 15, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Misassembled” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2019Misassembled; Misassembled

  ALLEGEDLY, APPROXIMATELY 2/3 OF THE WAY INTO A TURP PROCEDURE, THE ENDOMAT SUCTION PUMP WAS HOOKED UP; HOWEVER, THE PUMP TUBING WAS PLACED INCORRECTLY INTO THE PUMP, RESULTING IN THE FLUID INSIDE THE CANNISTER TO BE PUMPED BACK INTO THE PATIENT'S BLADDER. THIS CAUSED OVER-DISTENSION, INCREASED PRESSURE, AND FLUID RETENTION. POST-OP, THE PATIENT WAS KEPT IN ICU FOR A LONGER TIME THAN PLANNED TO MONITOR THE FLUID RETENTION CONDITION. THE PATIENT HAS BEEN RELEASED, AND HOSPITAL CONFIRMED THERE IS NO LONG-TERM IMPACT TO THE PATIENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9329203 ↗
• MalfunctionOct 11, 2017Misassembled; Misassembled

  ALLEGEDLY, DURING A TURP PROCEDURE, THE ENDOMAT PUMP TUBING WAS MISTAKENLY HOOKED UP BACKWARDS. THE DOCTOR NOTICED THE FLUID WAS COMING INFLOW INSTEAD OF OUTFLOW. THE HOSPITAL DID NOT BELIEVE THE WASTE FLUID REACHED THE PATIENT'S BLADDER BUT, AS A PRECAUTION, IV ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. HOSPITAL REPORTED THE PATIENT IS DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6942963 ↗