Hydro-Surg 0026870Recalls & reported problems
Davol Inc. · Hydro-Surg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33 cm Tip and Cojoined Suction and Irrigation Tubing · Class 2
All models of Hydro-Surg (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Davol Hydro-Surg laparoscopic irrigator is a surgical tool that flushes fluid and suctions during keyhole surgery. Most of its 209 reports describe fluid leaking from the device, often during setup, and some describe corrosion. The reports include 1 injury and no deaths. There is 1 open recall, saying the product cannot provide irrigation, which began in June 2022. No reports came in the last 12 months, versus 10 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 209
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 00801741000362), received between May 23, 2017 and May 22, 2025 — classified as 1 injury, 208 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (173 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Reports received per month
Recalls naming this device
- Jun 7, 2022Open, Classified
The product is not able to provide irrigation.
Z-1305-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak173
- Corroded67
- Detachment of Device or Device Component19
- Device Contamination with Chemical or Other Material6
- Overheating of Device5
- Smoking5
- Insufficient Device Problem Information4
- Thermal Decomposition of Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions180
- No Consequences Or Impact To Patient25
- No Patient Involvement2
- Laceration(s)1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 209 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, THREE HYDRO-SURG PLUS IRRIGATORS (DEVICE #1 , #2 & #3) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069861 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, FOUR HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2, #3 & #4) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069860 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, THREE HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2 & #3) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069844 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, FOUR HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2, #3 & #4) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069843 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, FOUR HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2, #3 & #4) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069842 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, THREE HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2 & #3) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069840 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, TWO HYDRO-SURG PLUS IRRIGATORS (DEVICE #1 & #2) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069838 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, TWO HYDRO-SURG PLUS IRRIGATORS (DEVICE #1 & #2) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069826 ↗MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING SET UP OF A PROCEDURE ON (B)(6) 2025, FOUR HYDRO-SURG LAP IRRIGATORS (DEVICE #1, #2, #3 & #4) WERE LEAKING IRRIGATION FLUID AFTER BEING PRIMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22069819 ↗MalfunctionJan 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING ROBOTIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025, HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR WAS LEAKED PREOPERATIVELY. IT WAS REPORTED THAT THE LEAKING WAS NOTED "AT CONNECTION" AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21284594 ↗MalfunctionSep 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING A PROCEDURE, THE WHITE CAP (ND VALVE BODY PLUG) OF HYDRO-SURG PLUS IRRIGATOR POPPED OFF CAUSING THE HANDLE TO LEAK IRRIGATION FLUID. IT WAS REPORTED THAT THE OR STAFF TIGHTENED THE WHITE CAP PRIOR TO USE TO ENSURE IT WAS SECURED ONTO THE ND HANDLE. IT WAS ALSO REPORTED THAT ANOTHER IRRIGATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20179705 ↗MalfunctionAug 1, 2024Break; Break
AS REPORTED, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE HYDRO-SURG IRRIGATOR BROKE AND MALFUNCTIONED DURING A CASE. IT WAS REPORTED THAT THE TWO DEVICES, THE PLASTIC AT THE END WHERE THE SUCTION TIP WAS CRACKED (MALE ADAPTER), MAKING IT IMPOSSIBLE TO GET THE PROPER SEAL AND SUCTION. THE SURGEON TRIED TURNING UP THE SUCTION FOR THE TWO THAT CRACKED BUT THE SUCTION TIP WOULD NOT STAY ATTACHED. IT WAS ALSO REPORTED THAT THE SURGEON USED ANOTHER NEW DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19882753 ↗MalfunctionJul 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING LAPAROSCOPIC HEMICOLECTOMY PROCEDURE ON (B)(6) 2024, THE PLASTIC WHITE CAP OF HYDRO-SURG IRRIGATOR FELL ONTO THE FLOOR WHEN HOOKING UP AT START OF CASE AND BECAME UNSTERILE. IT WAS REPORTED THAT TUBING DID NOT WORK, AND SUCTION COULD NOT BE MAINTAINED, IT WAS UNKNOWN WHETHER THE WHITE CAP WAS CHECKED AND SECURED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING ANOTHER HYDROSURG DEVICE OF THE SAME LOT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19646188 ↗MalfunctionMar 7, 2024Corroded; Fluid/Blood Leak; Corroded; Fluid/Blood Leak
AS REPORTED, DURING A PROCEDURE HYDRO-SURG HAD IRRIGATION FLUID LEAK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18861283 ↗MalfunctionFeb 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNKNOWN PROCEDURE HYDRO-SURG PLUS IRRIGATOR HAD A FLUID LEAK ISSUE. LEAKAGE ISSUE NOTED UPON HOOK UP OF THE IRRIGATION FLUID. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18784182 ↗MalfunctionFeb 26, 2024Corroded; Fluid/Blood Leak; Corroded; Fluid/Blood Leak
AS REPORTED, DURING A PROCEDURE, THE HYDRO-SURG LEAKED IRRIGATION FLUID IMMEDIATELY AFTER CONNECTING TO THE IRRIGATION FLUID. IT WAS REPORTED THAT NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18784153 ↗MalfunctionFeb 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A PROCEDURE, THE HYDRO-SURG HAD IRRIGATION FLUID LEAK. THERE WAS NO PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18784152 ↗MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A PROCEDURE, THE HYDRO-SURG LEAKED IRRIGATION FLUID WHERE THE TUBING AND BATTERY COMPARTMENT CONNECT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18713231 ↗MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG LEAKED IRRIGATION FLUID WHERE THE TUBING AND BATTERY COMPARTMENT CONNECT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18713230 ↗MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG LEAKED IRRIGATION FLUID WHERE THE TUBING AND BATTERY COMPARTMENT CONNECT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18713228 ↗MalfunctionFeb 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A PROCEDURE, THE HYDRO-SURG LEAKED IRRIGATION FLUID WHERE THE TUBING AND BATTERY COMPARTMENT CONNECT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18713091 ↗MalfunctionFeb 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNKNOWN PROCEDURE HYDRO-SURG PLUS IRRIGATOR HAD A FLUID LEAK ISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18640076 ↗MalfunctionFeb 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNKNOWN PROCEDURE HYDRO-SURG PLUS IRRIGATOR HAD A FLUID LEAK ISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18640075 ↗MalfunctionFeb 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A ROBOTIC-ASSISTED HYSTERECTOMY PROCEDURE HYDRO-SURG IRRIGATOR DEVICE WAS LEAKING IRRIGATION FLUID AT THE BASE OF THE PUMP ASSEMBLY IN THE BEGINNING OF A PROCEDURE AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18640072 ↗MalfunctionFeb 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNKNOWN PROCEDURE HYDRO-SURG PLUS IRRIGATOR HAD A FLUID LEAK ISSUE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18640068 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page