Hydro-Surg 5600160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741077203), received between Apr 7, 2017 and Apr 11, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Arcing” (3 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 16, 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.

• MalfunctionApr 11, 2019Arcing; Arcing

  IT WAS REPORTED THAT THE INSULATION AROUND THE L-HOOK WAS NOT WORKING PROPERLY DURING A LAPAROSCOPIC CHOLECYSTECTOMY AND THE CURRENT WAS GOING OUT THE SIDES OF THE HOOK AND NOT JUST THE TIP. IT WAS ALLEGED IT WAS ALMOST LIKE THERE WAS NO INSULATION. CUSTOMER NOTED THEY WERE CAUTERIZING LIVER AND SURROUNDING TISSUES. A BOVIE PENCIL WAS ALSO IN USE. THE COAG SETTING AT THE TIME OF THE ISSUE WAS SET AT 20. THE L-HOOK WAS SWITCHED OUT AND THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT INJURY OR ANY INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503746 ↗
• MalfunctionMay 11, 2017Arcing; Insufficient Device Problem Information; Arcing; Insufficient Device Problem Information

  INFORMATION AS REPORTED BY THE USER FACILITY: "WE HAVE HAD AN ISSUE OF ARCING OFF AND ON WHILE USING THIS DISPOSABLE LAPAROSCOPIC INSTRUMENT. WE REVIEWED THE MANUFACTURER¿S IFU, IT EXPLICITLY STATES TO USE ONLY WITH METAL CANNULA¿S. WE USE APPLIED MEDICAL AND ETHICON, NEITHER OF WHICH HAS A METAL CANNULA." THE IRRIGATION FLUID WAS CLEARED PRIOR TO ACTUATION OF THE ELECTROSURGICAL UNIT. NO METAL TROCARS WERE USED AND THE ELECTROSURGICAL PROBE WAS INSERTED THROUGH THE PROPER SIZED (NON METAL) TROCAR. CONTACT DOES NOT KNOW WHAT THE GENERATOR VOLTAGE WAS SET AT. THE ELECTROSURGICAL ATTACHMENT TIP WAS RETRACTED AND LOCKED INTO THE ELECTROSURGICAL SHEATH WHEN ENTERING AND EXITING THE ABDOMEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6561738 ↗
• InjuryApr 7, 2017Arcing; Arcing

  INFORMATION AS REPORTED BY THE MAUDE REPORT (MW5068097): SURGEON EXPERIENCED L HOOK DEVICE UNCONTROLLED "ARCING" DURING A LAPAROSCOPIC PROCEDURE. THIS CAUSED AN INCIDENTAL BURN OF THE LIVER WHEN CAUTERIZING THE GALL BLADDER. ADDITIONAL INFORMATION AS REPORTED BY THE USER FACILITY: DURING USE OF A DISPOSABLE L-HOOK ELECTROSURGICAL ELECTRODE IN A LAPAROSCOPIC PROCEDURE, THE DEVICE ARCED. THIS CAUSED AN INCIDENTAL BURN OF THE LIVER WHEN CAUTERIZING THE GALL BLADDER. THE DEVICE WAS NOT BEING USED WITH ANY OTHER DEVICES AND THERE WAS NO DAMAGE NOTED TO THE OUTER SHEATH. THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE EVENT. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 6471341 ↗