DeRoyal 28-0801Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00749756025355), received between Aug 12, 2019 and Nov 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Material Fragmentation; Material Fragmentation

  A USER FACILITY REPORTED THROUGH A MEDWATCH, "DURING SURGERY, SURGEON REMOVED 5MM LAPAROSCOPIC KITTNER DISSECTOR FROM THE ABDOMEN, AND THE SCRUB TECH NOTICED THE TIP PIECE OF KITTNER WAS NOT ATTACHED. SURGEON WAS ABLE TO LOCATE THE KITTNER TIP AND SAFELY REMOVE IT FROM THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568870 ↗
• MalfunctionJun 5, 2025Break; Break

  A USER FACILITY REPORTED, "LAPAROSCOPIC DISSECTOR TIP BROKE OFF IN PATIENT. TIP WAS RETRIEVED AND NO INJURY OCCURRED TO PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151906 ↗
• MalfunctionApr 30, 2025Break; Break

  A USER FACILITY REPORTED, "TIP BROKE OFF THE HANDLE." NO INJURIES WERE REPORTED, BUT A DELAY OF PROCEDURE WAS NOTED. NO SPECIFICS ON LENGTH OF DELAY OR ANY OUTCOMES RELATED TO THE DELAY WERE GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937250 ↗
• MalfunctionApr 30, 2025Break; Break

  A USER FACILITY REPORTED, "THE TIP BROKE OFF." NO INJURIES WERE REPORTED, BUT A DELAY OF PROCEDURE WAS NOTED. NO SPECIFICS ON LENGTH OF DELAY OR ANY OUTCOMES RELATED TO THE DELAY WERE GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937249 ↗
• MalfunctionAug 12, 2019Break; Material Integrity Problem; Break; Material Integrity Problem

  SMALL DELAY WITH PROCEDURE GETTING A NEW KITTNER TIP. THE ENTIRE GAUZE TIP CAME OFF OF THE END OF THE DISSECTOR WHILE IN USE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883374 ↗