Hydro-Surg 5600200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741077227), received between May 22, 2019 and May 22, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionMay 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED PER THE USER FACILITY THAT THE BLACK COATING ON THE REUSABLE NEEDLE POINT CAUTERY TIPS IS FALLING OFF AFTER JUST ONE STERILIZATION. CONTACT CONFIRMED THAT A PIECE DETACHED WHEN CLEANING THE TIP, AND THERE IS CONCERN THIS COULD RESULT IN THE PIECE COMING OFF IN USE. THERE WAS NO REPORTED PATIENT INJURY/COMPLICATION AS A RESULT OF THE PROBLEM EXPERIENCED. ADDENDUM: IN FOLLOW UP WITH THE USER FACILITY CONTACTS THEY REPORTED THE DEVICE WAS USED IN LAP TOTAL HYSTERECTOMY PROCEDURE. THE PROBLEM PRESENTED DURING FIRST USE OF THE DEVICE, AND FOLLOWING THE CLEANING STERILIZATION PROTOCOL OF THE NON-STERILE REUSABLE DEVICE. THE ELECTRO CAUTERY TIP WAS BEING CLEARED OF DEBRIS BY THE OR TECH USING A WET SPONGE. THE INSULATION MATERIAL AFFIXED TO THE DISTAL END OF THE DEVICE APPEARED TO HAVE PHYSICALLY CRACKED AND SPLIT AND THE MATERIAL CAME OFF IN THE SPONGE IN TWO SMALL PIECES. THE PIECES WERE DISCARDED. STAFF CONFORMED THAT THERE WAS NOTHING THAT FELL INTO THE BODY, AND NO PATIENT IMPACT AS A RESULT OF THE PROBLEM THE WAS EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633473 ↗
• MalfunctionMay 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED PER THE USER FACILITY THAT THE BLACK COATING ON THE REUSABLE NEEDLE POINT CAUTERY TIPS IS FALLING OFF AFTER JUST ONE STERILIZATION. CONTACT CONFIRMED THAT A PIECE DETACHED WHEN CLEANING THE TIP, AND THERE IS CONCERN THIS COULD RESULT IN THE PIECE COMING OFF DURING USE. THERE WAS NO REPORTED PATIENT INJURY/COMPLICATION AS A RESULT OF THE PROBLEM EXPERIENCED. ADDENDUM: IN FOLLOW UP WITH THE USER FACILITY CONTACTS THEY REPORTED THE DEVICE WAS USED IN LAP TOTAL HYSTERECTOMY PROCEDURE. THE PROBLEM PRESENTED DURING FIRST USE OF THE DEVICE, AND FOLLOWING THE CLEANING STERILIZATION PROTOCOL OF THE NON-STERILE REUSABLE DEVICE. THE ELECTRO CAUTERY TIP WAS BEING CLEARED OF DEBRIS BY THE OR TECH USING A WET SPONGE. THE INSULATION MATERIAL AFFIXED TO THE DISTAL END OF THE DEVICE APPEARED TO HAVE PHYSICALLY CRACKED AND SPLIT AND THE MATERIAL CAME OFF IN THE SPONGE IN TWO SMALL PIECES. THE PIECES WERE DISCARDED. STAFF CONFORMED THAT THERE WAS NOTHING THAT FELL INTO THE BODY, AND NO PATIENT IMPACT AS A RESULT OF THE PROBLEM THE WAS EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633409 ↗