Hydro-Surg 0026880Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00801741010224), received between Aug 3, 2017 and Nov 22, 2024 — classified as 1 injury, 86 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (79 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 7, 2022Open, Classified

   The product is not able to provide irrigation.

   Z-1304-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE, THE MALE (QD) ADAPTOR ON THE ND TRUMPET VALVE OF THE HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR BROKE OFF. IT WAS REPORTED THAT ALL PIECES WERE REMOVED, A NEW HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20763386 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG PLUS LEAKED IRRIGATION FLUID FROM THE PLASTIC PIECE OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046256 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG PLUS LEAKED IRRIGATION FLUID FROM THE PLASTIC PIECE OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19045984 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG PLUS LEAKED IRRIGATION FLUID FROM THE PLASTIC PIECE OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19045886 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG PLUS LEAKED IRRIGATION FLUID FROM THE PLASTIC PIECE OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19045855 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG PLUS LEAKED IRRIGATION FLUID FROM THE PLASTIC PIECE OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19045843 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG PLUS LEAKED IRRIGATION FLUID FROM THE PLASTIC PIECE OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19045774 ↗
• MalfunctionApr 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HYDRO-SURG PLUS LEAKED IRRIGATION FLUID FROM THE PLASTIC PIECE OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19030565 ↗
• MalfunctionApr 12, 2023Smoking; Smoking

  AS REPORTED, DURING A LAPAROSCOPIC BILATERAL SALPINGECTOMY, THE HYDRO-SURG IRRIGATOR WAS SET UP AND READY FOR USE. PRIOR TO INCISION THE IRRIGATOR HAD A BURNING PLASTIC SMELL, WAS NOTED TO BE SMOKING AND THE ITEM WAS FOUND TO BE HOT TO TOUCH. THE DEVICE WAS SUBMERGED INTO COOL WATER IMMEDIATELY. THE SURGEON DECIDED TO NOT USE ANYTHING IN PLACE OF IT. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726035 ↗
• MalfunctionJan 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, A BARD/DAVOL HYDROSURG LAPAROSCOPIC IRRIGATOR LEAKED IRRIGATION FLUID FROM PUMP ASSEMBLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13278512 ↗
• MalfunctionJan 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, A BARD/DAVOL HYDROSURG IRRIGATION DEVICE LEAKED IRRIGATION FLUID FROM PUMP ASSEMBLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235085 ↗
• MalfunctionDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A TOTAL JOINT PROCEDURE, THE BARD/DAVOL HYDROSURG LAPAROSCOPIC IRRIGATOR LEAKED FLUID. IT WAS REPORTED THAT THE DEVICE WAS DISCARDED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT FUNCTION AS INTENDED DUE TO THE LEAKAGE AT THE BATTERY CASE. THERE WAS NO REPORTED PATIENT HARM OR INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962200 ↗
• MalfunctionDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A TOTAL JOINT PROCEDURE, THE BARD/DAVOL HYDROSURG LAPAROSCOPIC IRRIGATOR LEAKED FLUID. IT WAS REPORTED THAT THE DEVICE WAS DISCARDED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT FUNCTION AS INTENDED DUE TO THE LEAKAGE AT THE BATTERY CASE. THERE WAS NO REPORTED PATIENT HARM OR INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12962191 ↗
• MalfunctionNov 17, 2021Component Missing; Component Missing

  AS REPORTED, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL HYDROSURG PLUS LAPAROSCOPIC IRRIGATOR DEVICE WAS PRESENTED FOR USE. IT WAS IDENTIFIED THAT THE THREADED CAP ON THE ND HANDLE WAS MISSING. THE PRODUCT PACKAGING IS REPORTED AS BEING COMPLETELY SEALED PRIOR TO OPENING FOR THE CASE AND NOTING THE MISSING COMPONENT. AS REPORTED, THERE WAS NO PROLONGATION OF SURGERY TIME AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. ATTEMPTED USE OF THE DEVICE WITH THE CAP MISSING WOULD RESULT IN FLUID LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12830603 ↗
• MalfunctionNov 10, 2021Corroded; Fluid/Blood Leak; Corroded; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE THE BARD/DAVOL HYDRO-SURG IRRIGATION DEVICE WOULD NOT IRRIGATE OR SUCTION PROPERLY AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT WHEN REMOVING THE DEVICE FROM THE IV POLE, THE OR STAFF NOTED THAT THERE WAS A SMALL AMOUNT OF IRRIGATION FLUID LEAKING FROM THE BATTERY PACK AND THE DEVICE WAS VERY HOT TO TOUCH. AS REPORTED, ANOTHER BARD/DAVOL HYDRO-SURG IRRIGATION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788842 ↗
• MalfunctionOct 15, 2021Corroded; Fluid/Blood Leak; Corroded; Fluid/Blood Leak

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL HYDROSURG PLUS W/ SMOKEVAC TRUMPET VALVE & TIP LEAKED FLUID FROM THE BATTERY COMPARTMENT. AS REPORTED, THE LENGTH OF DEVICE USE IS UNKNOWN THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638129 ↗
• MalfunctionSep 30, 2021Corroded; Fluid/Blood Leak; Corroded; Fluid/Blood Leak

  AS REPORTED, AT THE END OF A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL HYDROSURG IRRIGATION DEVICE WAS USED FOR ABOUT 1 MINUTE. THE OR STAFF NOTICED THE DEVICE BEGAN LEAKING DISCOLORED (YELLOW) FLUID FROM THE BATTERY PACK IMMEDIATELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12557636 ↗
• MalfunctionSep 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, A BARD/DAVOL HYDRO-SURG IRRIGATION DEVICE WAS USED. IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, A DISCOLORED FLUID FROM BATTERY HOUSING WAS NOTED. IT WAS REPORTED THAT THE DEVICE WORKED DURING THE PROCEDURE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540604 ↗
• MalfunctionSep 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE BARD/DAVOL HYDROSURG PLUS IRRIGATOR DEVICE LEAKED A BROWN COLORED FLUID FROM THE BATTERY HOUSING DURING USE. IT WAS REPORTED THAT THE FLUID LEAK WAS NOTED AFTER SPIKING AND PRIMING THE IV BAG. THE DEVICE WAS USED FOR THE ENTIRE CASE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468880 ↗
• MalfunctionSep 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE BARD/DAVOL HYDROSURG PLUS IRRIGATOR DEVICE LEAKED A BROWN COLORED FLUID FROM THE BATTERY HOUSING DURING USE. IT WAS REPORTED THAT THE FLUID LEAK WAS NOTED AFTER SPIKING AND PRIMING THE IV BAG. THE DEVICE WAS USED FOR THE ENTIRE CASE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468879 ↗
• MalfunctionSep 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE THE HYDROSURG LAP IRRIGATION DEVICE WAS LEAKING A BROWN COLORED FLUID FROM THE BATTERY HOUSING DURING USE. IT WAS REPORTED THAT THE FLUID LEAK WAS NOTED AFTER SPIKING AND PRIMING THE IV BAG BUT THE DEVICE WAS USED FOR THE ENTIRE CASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468878 ↗
• MalfunctionSep 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, A BARD/DAVOL HYDROSURG PLUS IRRIGATOR DEVICE WAS NOTED TO BE LEAKING IRRIGATION FLUID, BROWNISH IN COLOR THROUGH THE BATTERY COMPARTMENT. IT WAS REPORTED THAT THE FLUID LEAK WAS NOTED AFTER SPIKING AND PRIMING THE IV BAG. THE DEVICE WAS USED FOR THE ENTIRE CASE. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442409 ↗
• MalfunctionSep 7, 2021Corroded; Fluid/Blood Leak; Corroded; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, A BARD/DAVOL HYDROSURG IRRIGATION DEVICE WAS USED. IT WAS REPORTED THAT AT THE END OF THE CASE WHILE REMOVING THE IRRIGATOR FROM THE IV POLE/NEPTUNE, THE IRRIGATOR WAS LEAKING FLUID FROM THE BATTERY PACK. THERE WAS NO PERFORMANCE ISSUE AND THE DEVICE FUNCTIONED AS INTENDED. THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434804 ↗
• MalfunctionSep 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE A BARD/DAVOL HYDROSURG IRRIGATION DEVICE WAS LEAKING FLUID FROM THE BATTERY COMPARTMENT. IT WAS REPORTED THAT THE DEVICE DID FUNCTION AS INTENDED. THERE WAS NO REPORTED HARM TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433213 ↗
• MalfunctionSep 7, 2021Corroded; Fluid/Blood Leak; Corroded; Fluid/Blood Leak

  AS REPORTED, ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE BARD/DAVOL HYDRO-SURG IRRIGATION DEVICE WAS USED. IT WAS REPORTED THAT FLUID LEAK WAS NOTED AT THE END OF THE CASE WHILE REMOVING THE IRRIGATOR FROM THE IV POLE/NEPTUNE. THE DEVICE DID FUNCTION AS INTENDED. THERE WAS NO APPARENT HARM TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433117 ↗