Hydro-Surg 5539700Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741077081), received between Oct 27, 2021 and Oct 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2021Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  CUSTOMER REPORTED THAT THE REUSABLE 10 MM IRRIGATION QD PROBE TIP DID NOT FIT ONTO THE ND IRRIGATION TUBING SET. IT WAS REPORTED THAT IT FALLS OFF DURING THE CASE. CONTACT REPORTED THAT NO PATIENT HARM HAS RESULTED, BUT THAT IT ALSO HAPPENED SEVERAL WEEKS AGO WITH A DIFFERENT 10MM TIP. ALLEGED THEY DID NOT HEAR OR FEEL THE INDICATIVE CLICKS THAT USUALLY CONFIRM THE PRODUCT IS SECURE. THE CONTACT WAS UNABLE TO PROVIDE CASE SPECIFIC DETAILS TO KNOW IF THE PROBLEM RESULTED IN A POSSIBLE DETACHMENT IN USE ON THE PATIENT OR IF A FLUID LEAK PRESENTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705619 ↗
• MalfunctionOct 27, 2021Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  CUSTOMER REPORTED THAT THE REUSABLE 10 MM IRRIGATION QD PROBE TIP DID NOT FIT ONTO THE ND IRRIGATION TUBING SET. IT WAS REPORTED THAT IT FALLS OFF DURING THE CASE. CONTACT REPORTED THAT NO PATIENT HARM HAS RESULTED, BUT THAT IT ALSO HAPPENED SEVERAL WEEKS AGO WITH A DIFFERENT 10MM TIP. ALLEGED THEY DID NOT HEAR OR FEEL THE INDICATIVE CLICKS THAT USUALLY CONFIRM THE PRODUCT IS SECURE. THE CONTACT WAS UNABLE TO PROVIDE CASE SPECIFIC DETAILS TO KNOW IF THE PROBLEM RESULTED IN A POSSIBLE DETACHMENT IN USE ON THE PATIENT OR IF A FLUID LEAK PRESENTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705610 ↗