Hydro-Surg 5600240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741077234), received between Nov 12, 2021 and Apr 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 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.

• MalfunctionApr 13, 2022Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THE BARD/DAVOL J-HOOK ELECTROSURGICAL REUSABLE TIP (WHICH REQUIRES REPROCESSING CLEANING/STERILIZATION BETWEEN CASES) WAS USED AND STERILIZED 3 TIMES PRIOR TO NOTING THE RUBBER SHEATH AROUND THE TIP WAS SEPARATED. AS REPORTED, THERE WAS NO ISSUE WITH THE DEVICE DURING USAGE AND NO REPORTED PATIENT INJURY. AS REPORTED, THE USER FACILITY HAS NOT MADE CHANGES TO THE STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106357 ↗
• MalfunctionNov 12, 2021Degraded; Degraded

  AS REPORTED, THE BARD/DAVOL J-HOOK ELECTROSURGICAL TIP (RE-USABLE) FAILED AFTER 4 USES. AS REPORTED, THE METAL TIP IS USUALLY 2MM AWAY AND THERE WAS DAMAGE/TEARS/WEAR TO THE INSULATION COATING. IT WAS REPORTED THAT THE DEVICE FAILED THE INSULATION TEST WHEN TESTED WITH AN INSULATION TESTER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12806400 ↗