CUSA® Excel C4613SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780026044), received between Feb 25, 2022 and Apr 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (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 10, 2026Accessory Incompatible

  A FACILITY REPORTED THAT THEY ENCOUNTERED DIFFICULTY TO SCREW THE CUSA EXCEL 36KHZ STANDARDTIP STRAIGHT TIP (C4613S) INTO THE EXCEL 36KHZ HANDPIECE. THE USER TRIED THE 2ND SET OF C4613S TIP WITH THE SAME BATCH AND THE ISSUE STILL OCCURRED. ANOTHER BATCH OF C4613S TIP WAS SCREWED INTO THE SAME HANDPIECE, AND THE ISSUE WAS RESOLVED. THE SURGERY WAS DELAYED FOR APPROXIMATELY 30 MINUTES DUE TO PRODUCT DEFECT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839735 ↗
• MalfunctionFeb 25, 2022Output Problem; Output Problem

  THIS IS 3 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3006697299-2022-00021, 3006697299-2022-00022, AND 3006697299-2022-00024. A FACILITY REPORTED THAT THE AMPLITUDE COULD NOT GO UP DURING FRAGMENTATION. THEY CHANGED TO A NEW TIP AND CONSUMABLES. CUSA EXCEL 36KHZ STANDARDTIP STRAIGHT (C4613S) WAS INVOLVED, AND SURGICAL DELAY OF 30-40 MINUTES WAS REPORTED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599642 ↗