CUSA® Excel C2602Recalls & reported problems
Integra Lifesciences (Ireland) Limited · CUSA® Excel Cusa Excel 36KHz Handpiece · Class U
Quick summary
This Integra CUSA Excel handpiece is an ultrasonic surgical instrument used to cut or coagulate tissue during operations. The 43 reports mostly describe the handpiece overheating, losing power, or its connection coming loose mid-surgery, which in some cases lengthened procedures. Two reports involve injuries, including burns, and no deaths were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10381780039433), received between Feb 17, 2022 and Jul 27, 2026 — classified as 2 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (17 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device17
- Energy Output Problem6
- Incorrect, Inadequate or Imprecise Result or Readings6
- Power Problem5
- Inability to Irrigate3
- Output Problem3
- Output below Specifications2
- Audible Prompt/Feedback Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Burn(s)2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025488 ↗MalfunctionFeb 6, 2026Energy Output Problem
AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE IS DEFECTIVE WHICH RESULTED IN INCREASED SURGICAL TIME OF 30 MINUTES OR MORE. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279050 ↗InjuryNov 13, 2025Overheating of Device; Overheating of Device
MalfunctionSep 22, 2025Inability to Irrigate; Overheating of Device; Inability to Irrigate; Overheating of Device
MalfunctionSep 22, 2025Overheating of Device; Overheating of Device
MalfunctionSep 16, 2025Overheating of Device; Overheating of Device
A FACILITY RETURNED THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE EACH1 (C2602) WHICH FAILED THE INCOMING PERFORMANCE TEST WITH A STROKE OF 7.7MILS AND WAS ALSO OVER-HEATING ON 10 MINUTES TEST. THERE WAS NO PATIENT INVOLVEMENT OR USER INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23061971 ↗MalfunctionAug 22, 2025Energy Output Problem; Energy Output Problem
MalfunctionAug 22, 2025Energy Output Problem; Energy Output Problem
MalfunctionJul 21, 2025Failure to Deliver Energy; Output below Specifications; Failure to Deliver Energy; Output below Specifications
MalfunctionMay 21, 2025Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602) EMITTED "TIP VIBRATION ERROR" AND HEATS UP EXCESSIVELY DURING OPERATION AFTER 2-3 MINUTES. THE HANDPIECE WAS REPLACED AND THE BREAK IN THE OPERATION LASTED AS LONG AS IT TOOK TO REPLACE THE HANDPIECE IN THE CUSA EXCEL CONSOLE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060572 ↗MalfunctionMar 13, 2025Inability to Irrigate; Intermittent Loss of Power; Inability to Irrigate; Intermittent Loss of Power
THIS REPORT IS FOR THE 2ND HANDPIECE USED IN THIS CASE AND IS LINKED TO MFG REPORT NUMBERS 3006697299-2025-00030 AND 3006697299-2025-00031: A DEFECT OCCURRED DURING SURGERY: THE CUSA EXCEL HAD A COOLING WATER ALARM: THE HANDPIECE (HP) (ET4662, (B)(4) (TIP) WAS INSTALLED CORRECTLY. WHILE TESTING THE HP, THE AMPLITUDE LIGHT ONLY ROSE TO 10% INSTEAD OF THE 100%, SO GIVING HP ALARM. WHEN TESTING THE HP AGAIN, THEN IT GAVE COOLING WATER ALARM. A SECOND CUSA HP (B)(6), (B)(4) WAS USED AND WORKED 1 OR 2 TIMES AND WENT BACK IN COOLING WATER ALARM MANY TIMES. THE SURGERY TEAM CONTINUED SURGERY WITH THE CUSA EXCEL AFTER EACH USE (OF 30 SECONDS (+/-?) SHUT DOWN CUSA AND STARTING IT UP AGAIN. THE SURGERY WAS EXTENDED FOR MORE THAN 30 MINUTES. THE THIRD HP (B)(6), (B)(4) WAS TESTED ALSO DURING THE SURGERY BUT DIDN'T WORK. (THE SALES REP SAID THAT IT WAS OVERTORQUED). THE SURGICAL OUTCOME WAS OK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599754 ↗MalfunctionMar 13, 2025Misassembled During Installation; Misassembled During Installation
THIS REPORT IS 3 OF 3 FOR THE 3RD HANDPIECE USED IN THE CASE AND IS LINKED TO MFG REPORT NUMBERS 3006697299-2025-00028 AND 3006697299-2025-00031: A DEFECT OCCURRED DURING SURGERY: THE CUSA EXCEL HAD A COOLING WATER ALARM: THE HANDPIECE (HP) (ET4662, PR (B)(4)) (TIP) WAS INSTALLED CORRECTLY. WHILE TESTING THE HP, THE AMPLITUDE LIGHT ONLY ROSE TO 10% INSTEAD OF THE 100%, SO GIVING HP ALARM. WHEN TESTING THE HP AGAIN, THEN IT GAVE COOLING WATER ALARM. A SECOND CUSA HP (B)(6) (PR (B)(4)) WAS USED AND WORKED 1 OR 2 TIMES AND WENT BACK IN COOLING WATER ALARM MANY TIMES. THE SURGERY TEAM CONTINUED SURGERY WITH THE CUSA EXCEL AFTER EACH USE (OF 30 SECONDS (+/-?)) SHUT DOWN CUSA AND STARTING IT UP AGAIN. THE SURGERY WAS EXTENDED FOR MORE THAN 30 MINUTES. THE THIRD HP (B)(6) (PR (B)(4)) WAS TESTED ALSO DURING THE SURGERY BUT DIDN'T WORK. (THE SALES REP SAID THAT IT WAS OVERTORQUED). THE SURGICAL OUTCOME WAS OK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599751 ↗MalfunctionMar 13, 2025Inability to Irrigate; Loose or Intermittent Connection; Inability to Irrigate; Loose or Intermittent Connection
THIS REPORT IS FOR THE 1ST HANDPIECE USED IN THIS CASE AND IS LINKED TO MFG REPORT NUMBERS 3006697299-2025-00028 AND 3006697299-2025-00030: A DEFECT OCCURRED DURING SURGERY: THE CUSA EXCEL HAD A COOLING WATER ALARM: THE HANDPIECE (HP) ((B)(6), (B)(4) (TIP) WAS INSTALLED CORRECTLY. WHILE TESTING THE HP, THE AMPLITUDE LIGHT ONLY ROSE TO 10% INSTEAD OF THE 100%, SO GIVING HP ALARM. WHEN TESTING THE HP AGAIN, THEN IT GAVE COOLING WATER ALARM. A SECOND CUSA HP (B)(6), (B)(4) WAS USED AND WORKED 1 OR 2 TIMES AND WENT BACK IN COOLING WATER ALARM MANY TIMES. THE SURGERY TEAM CONTINUED SURGERY WITH THE CUSA EXCEL AFTER EACH USE (OF 30 SECONDS (+/-?) SHUT DOWN CUSA AND STARTING IT UP AGAIN. THE SURGERY WAS EXTENDED FOR MORE THAN 30 MINUTES. THE THIRD HP (B)(6), (B)(4) WAS TESTED ALSO DURING THE SURGERY BUT DIDN'T WORK. (THE SALES REP SAID THAT IT WAS OVERTORQUED). THE SURGICAL OUTCOME WAS OK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599749 ↗MalfunctionFeb 6, 2025Overheating of Device; Overheating of Device
A DISTRIBUTOR REPORTED THAT THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602) WAS HEATING DURING A LIVER SURGERY AND HAD NO FREQUENCY. THERE WAS NO PATIENT INJURY AND NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21323521 ↗MalfunctionJan 31, 2025Overheating of Device; Overheating of Device
AN AUTHORIZED DISTRIBUTOR REPORTED THAT THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602) WAS HEATING DURING A LIVER SURGERY AND HAD LOW AMPLITUDE OUTPUT. THERE WAS NO PATIENT INJURY AND NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21283178 ↗MalfunctionJan 31, 2025Output below Specifications; Output below Specifications
A FACILITY REPORTED THAT DURING SURGERY, THE ULTRASOUND FROM THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602) WAS TOO LOW. THERE WAS INCREASED SURGICAL TIME OF 30 MINUTES; HOWEVER, THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21282912 ↗MalfunctionDec 27, 2024Overheating of Device; Overheating of Device
A FACILITY REPORTED THAT THE HANDLE ON THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602) WAS VERY HOT. NO INFORMATION ON PATIENT INVOLVEMENT OR SURGICAL DELAY HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21027327 ↗MalfunctionJun 7, 2024Energy Output Problem; Energy Output Problem
THIS REPORT IS LINKED TO MFG REPORT NUMBERS: 3006697299-2024-00072. 3006697299-2024-00076. 3006697299-2024-00079. A FACILITY REPORTED THAT DURING A CRANIOTOMY TUMOR REMOVAL SURGERY, THE SURGEON WAS USING A CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602), AND IT WAS NOT REMOVING THE TISSUE WELL AND AS EFFICIENTLY AS EXPECTED, SO THEY SWAPPED TO ANOTHER HANDPIECE, AND IT WAS BETTER BUT STILL NOT AS WELL AS EXPECTED. THE SURGEON CONTINUED USING AND COMPLETED THE PROCEDURE WITH THE SWAPPED HANDPIECE. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS A DELAY OF 30 MINUTES AS THEY SWAPPED FOR ANOTHER HANDPIECE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION STATES THAT TWO 36KHZ HANDPIECES DID NOT WORK PROPERLY DURING THE CASE, BUT THAT THE FACILITY WILL BE RETURNING ALL HANDPIECES FOR INSPECTION. HOWEVER, SINCE CUSTOMER DID NOT REPORT WHICH OF THE 36KHZ HANDPIECES WERE USED, MDRS ARE BEING SUBMITTED FOR ALL 4 DEVICES BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19492071 ↗MalfunctionJun 7, 2024Energy Output Problem; Energy Output Problem
THIS IS LINKED TO MFG REPORT NUMBERS: 3006697299-2024-00072, 3006697299-2024-00078, 3006697299-2024-00079. A FACILITY REPORTED THAT DURING A CRANIOTOMY TUMOR REMOVAL SURGERY, THE SURGEON WAS USING A CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602), AND IT WAS NOT REMOVING THE TISSUE WELL AND AS EFFICIENTLY AS EXPECTED, SO THEY SWAPPED TO ANOTHER HANDPIECE, AND IT WAS BETTER BUT STILL NOT AS WELL AS EXPECTED. THE SURGEON CONTINUED USING AND COMPLETED THE PROCEDURE WITH THE SWAPPED HANDPIECE. THERE WAS NO PATIENT INJURY; HOWEVER, THERE WAS A DELAY OF 30 MINUTES AS THEY SWAPPED FOR ANOTHER HANDPIECE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION STATES THAT TWO 36KHZ HANDPIECES DID NOT WORK PROPERLY DURING THE CASE, BUT THAT THE FACILITY WILL BE RETURNING ALL HANDPIECES FOR INSPECTION. HOWEVER, SINCE CUSTOMER DID NOT REPORT WHICH OF THE 36KHZ HANDPIECES WERE USED, MDRS ARE BEING SUBMITTED FOR ALL 4 DEVICES BEING RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19489090 ↗MalfunctionApr 25, 2024Smoking; Intermittent Energy Output; Smoking; Intermittent Energy Output
A DISTRIBUTOR REPORTED THAT DURING "REMOVAL OF ABDOMINAL ABSCESS" PROCEDURE, THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602) FAILED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED INDICATING THE FOLLOWING: "AFTER 2 HOURS OF USING THE CUSA EXCEL ((B)(4)) WITHOUT INTERVALS, IT STOPPED AND TURNED ON ALL THE LIGHTS AND IT TOOK AN AVERAGE OF 3 MINUTES TO RETURN TO OPERATION, I REDID THE INITIAL TESTS, THE DOCTOR STARTED USING IT AGAIN BUT REPORTED THAT HE SMELLED BURNING, BUT I DIDN'T SMELL ANY BURNING SMELL AND NEITHER DID ANYONE ELSE IN THE ROOM. HE TOOK ANOTHER 5-MINUTE BREAK AND WAS ABLE TO USE IT UNTIL THE END OF THE SURGERY. POWER DROP DURING OPERATION, CONFIRMED IN THE TECHNICAL ASSISTANCE TEST.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19182571 ↗MalfunctionMar 29, 2024Crack; Crack
A FACILITY REPORTED THAT A CRACK WAS OBSERVED ON THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602), AND WHEN THE DYSFUNCTION WAS OBSERVED, PATIENT WAS ALREADY UNDER ANESTHESIA. A BACKUP HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS INCREASED SURGERY TIME OF 1 HOUR, BUT THERE WAS NO ADVERSE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19003927 ↗MalfunctionNov 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
MalfunctionOct 12, 2023Power Problem; Power Problem
A FACILITY REPORTED THAT THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602) BROKE DOWN FOR A THIRD TIME DURING SURGERY. EVEN THOUGH THE SUCTION, IRRIGATION AND AMPLITUDE WERE CHECKED BEFORE THE PROCEDURE, THE HANDPIECE JUST DID NOT WORK. THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE FAILURE OCCURRED, AND THE PROCEDURE WAS POSTPONED WHICH DISTURBED THE SURGERY SCHEDULE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17924105 ↗MalfunctionJul 3, 2023Power Problem; Power Problem
AN AUTHORIZED DISTRIBUTOR REPORTED THAT IN THE MIDDLE OF AN UNSPECIFIED PROCEDURE, A FACILITY SAW ON DISPLAY, A LIGHT HANDPIECE INDICATOR AND THEN THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE (C2602) STOPPED WORKING. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT; HOWEVER, THERE WAS SURGICAL DELAY OF APPROXIMATELY 30 MINUTES TO CHANGE THE HANDPIECE. SURGERY WAS CONTINUED WITH THE NEW HANDPIECE. THE FINAL USER (HOSPITAL NAME): (B)(6) HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17249812 ↗MalfunctionJun 29, 2023Overheating of Device; Output Problem; Overheating of Device; Output Problem
A FACILITY RETURNED THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE EACH1 (C2602) FOR "NO OUTPUT AND LOSS OF M-POWER" ISSUE. DURING TESTING OF THE HANDPIECE BY AN INTEGRA TECHNICIAN, IT WAS OBSERVED THAT BETWEEN THE TRANSDUCER AND HOUSING, THE TOP LIP OF THE HOUSING MELTED DUE TO FAULTY TRANSDUCER AND THE HEATING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT OR USER INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17225006 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.