Hydro-Surg 5600100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741077180), received between May 23, 2019 and May 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2019Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED PER THE USER FACILITY THAT THE BLACK COATING ON THE DISPOSABLE NEEDLE POINT CAUTERY TIPS FELL OFF. CONTACT CONFIRMED THAT A PIECE DETACHED WHEN CLEANING THE TIP, AND THERE IS CONCERN THIS COULD RESULT IN THE PIECE FALLING OFF DURING USE. THERE WAS NO REPORTED PATIENT INJURY/COMPLICATION AS A RESULT OF THE PROBLEM EXPERIENCED. ADDENDUM: INFORMATION PROVIDED DURING FOLLOW UP WITH USER FACILITY FOUND THAT THIS COMPLAINT WAS OPENED BASED ON ERRONEOUS INFORMATION. THE USER FACILITY CONFIRMED THERE WAS NO FAILURE THAT OCCURRED ASSOCIATED WITH THE ELECTROSURGICAL TIP (5600100) AS WAS PREVIOUSLY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8637133 ↗