V. Mueller NL4291-81TRecalls & reported problems
Steris Corporation · V. Mueller CLEANACCESS KERRISON RONGEUR T-COAT MICRO HANDLE 40DEG UP, 1MM BITE, 10MM OPENING SHAFT LENGTH 8 inches 20.3CM · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403187537), received between Nov 13, 2025 and Feb 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2026Fracture
DURING A LAMINECTOMY PROCEDURE, THE TIP OF THE KERRISON RONGEUR BROKE AND FELL INTO THE SURGICAL FIELD. IT WAS RETRIEVED WITH A BAYONET FORCEPS. THE PATIENT WAS FINE AND THE PROCEDURE WAS COMPLETED AS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24265786 ↗MalfunctionNov 13, 2025Break; Break
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TIP OF THEIR CLEANACCESS KERRISON RONGEUR T-COAT MICRO HANDLE "BROKE". THE TIP PIECE WAS IMMEDIATELY RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544743 ↗
Other RONGEUR, MANUAL devices
- Integra® Miltex® 26-332Integra Lifesciences Production Corporation · RONGEUR, MANUAL3 reports
- Symmetry DECKER 53-4000Aspen Surgical Products, Inc. · Rongeur, Manual3 reports
- Symmetry FERRIS-SMITH 53-1160Aspen Surgical Products, Inc. · Rongeur, Manual2 reports
- Symmetry Rapidclean® 53-1624LDAspen Surgical Products, Inc. · Rongeur, Manual2 reports
- V. Mueller NL6147Steris Corporation · RONGEUR, MANUAL2 reports
- Millennium 85-2481559Avalign Technologies, Inc. · RONGEUR, MANUAL1 report
- Symmetry KERRISON 53-1405Aspen Surgical Products, Inc. · Rongeur, Manual1 report
- Symmetry Surgical 51-1087Aspen Surgical Products, Inc. · Rongeur, Manual1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.