N/A (REF HAR9F)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327348248), received between Jun 21, 2018 and Mar 12, 2025 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 24, 2025Open, Classified

   Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.

   Z-0490-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT IN AN ENDOCRINE CASE, A TIP OF A HARMONIC FOCUS SHEAR (HAR9F) BROKE OFF DURING THE CASE. THE PIECE WAS RETRIEVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN FIVE MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583037 ↗
• InjuryNov 19, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED DURING THE PROCEDURE THAT THE FOCUS HAD BROKE. AS REPORTED, THE HANDPIECE WAS REMOVED FROM THE FIELD AND CASE PROCEEDED. X-RAY IMAGING WAS DONE AFTER THE PROCEDURE AS THE TIP COULD NOT BE LOCATED IN THE TRASH OR OR, WHICH WAS NEGATIVE FOR RETAINED FOREIGN BODY. IMAGING CONFIRMED THAT THE METAL TIP WAS NOT INSIDE OF THE PATIENT. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THERE WAS NO EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729953 ↗
• MalfunctionAug 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT A SHARP PIECE THAT FELL OFF THE DEVICE INTO THE PATIENT'S NECK AND ONTO CAROTID ARTERY WAS RETRIEVED DURING SURGERY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455556 ↗
• MalfunctionMay 22, 2023Insufficient Device Problem Information

  REPORT TO THE REPORTER STATES, "MALFUNCTION OF DEVICE".

  Patient problems: Insufficient Information

  MAUDE report 16973870 ↗
• MalfunctionAug 10, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE DEVICE MALFUNCTIONED. THE TIP OF THE DEVICE BROKE AT THE BEGINNING OF THE CASE WHILE IN USE BUT THE DEVICE WAS REPLACED AND SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME REPORTED WAS JUST A FEW MINUTES ONLY TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303079 ↗
• MalfunctionMay 4, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE HARMONIC SCALPEL KEPT FIRING AND NEVER TURNED OFF, CONTINUOUS ACTIVATION. THE EVENT OCCURRED AT THE BEGINNING OF THE CASE ON THE FIRST TRY. THE DOCTOR REMOVED THE DEVICE AND REPLACED IT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND MINIMAL EXTENDED PROCEDURE TIME WAS REPORTED TO BE A FEW MINUTES ONLY TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772759 ↗
• MalfunctionFeb 16, 2021Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE ACTIVATION BUTTON WAS STICKING. THE DEVICE WAS ACTIVATING ON ITS OWN. THE DEVICE WAS USED ON THE PATIENT AND REPLACED WITH A NEW STRYKER SUSTAINABILITY SOLUTIONS DEVICE. THE DEVICE WAS USED ON A GEN11 GENERATOR. THE SOFTWARE VERSION WAS UNKNOWN. THERE WAS NO PATIENT HARM OR BLOOD LOSS. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334208 ↗
• MalfunctionFeb 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS USING HARMONIC SCALPEL DURING SURGERY. THE TIP BROKE OFF THE INSTRUMENT AND THE OR TEAM HAD TO SEARCH FOR IT TO ENSURE THAT IT HAD NOT FALLEN INTO THE PATIENT. THE WIRE JAW OF THE HARMONIC SCALPEL WAS BROKEN DURING DISSECTION AND THE FRAGMENT WAS IDENTIFIED AND ACCOUNTED FOR BY THE END OF OPERATION. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11268482 ↗
• MalfunctionSep 4, 2020Connection Problem

  FROM STAFF: THE HARMONIC HANDPIECE WOULD NOT CONNECT WITH THE POWER SOURCE, AND WHILE DOING THE MANDATORY TESTING TO START IT UP, THE SURGICAL TECH FELT AN UNUSUAL CLICKING. WE CHOSE TO REPLACE IT WITH A NEW ONE AND EVERYTHING WORKED CORRECTLY WITH THE NEW HANDPIECE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10493593 ↗
• InjuryJul 24, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE HARMONIC SCALPEL WOULD NOT SEAL, CAUSING EXCESSIVE BLEEDING. THE COMPLAINANT DOES NOT KNOW THE AMOUNT OF BLOOD LOSS NOR IF A TRANSFUSION WAS ADMINISTERED. IT WAS REPORTED THEY HAD TO USE BETWEEN 40 AND 50 GAUZE'S TO ABSORB THE BLOOD LOSS. THE DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE EXTENDED PROCEDURE TIME WAS MINOR. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 10323634 ↗
• MalfunctionJul 24, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THE "MIN" POWER BUTTON KEPT BEEPING WHEN THE FINGER WAS LIFTED OFF THE BUTTON; IT WAS STUCK DOWN. THE DEVICE WAS NOT USED IN A PROCEDURE, RATHER THIS WAS A TRIAL CONDUCTED BY THE COMPANY REPRESENTATIVE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10323560 ↗
• MalfunctionMay 27, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED WHILE USING A HARMONIC SCALPEL (HAR9F), THE MINIMUM BUTTON WAS STICKING AND GOING OFF WHEN NOBODY WAS TOUCHING THE HANDPIECE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092772 ↗
• MalfunctionApr 24, 2020Physical Resistance/Sticking

  WHILST USING REPROCESSED HARMONIC HANDPIECE HAR9F, THE MINIMUM BUTTON WAS STICKING AND GOING OFF WHEN NOBODY WAS TOUCHING THE HANDPIECE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9995157 ↗
• MalfunctionMar 14, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THE ULTRASONIC SCALPEL HAR9F CONTINUED TO ACTIVATE AFTER THE DOCTOR HAD RELEASED THE HANDLE. THE SEAL WAS COMPLETED. THE DOCTOR REMOVED THE DEVICE OUT OF THE PATIENT WHILE STILL ACTIVATED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME WAS REPORTED TO BE LESS THAN A 5 MINUTE DELAY. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832781 ↗
• InjuryFeb 20, 2020Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE MAX BUTTON WOULD STICK AND THE HARMONIC REMAINED ACTIVATED. AN ALTERNATIVE METHOD WAS USED TO COMPLETE THE PROCEDURE AND EXTENDED PROCEDURE TIME REPORTED WAS SEVERAL MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9732360 ↗
• MalfunctionNov 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE WHITE PIECE BETWEEN THE SHEERS WAS MISSING/ BROKEN. SURGEON DID NOT NOTICE THE PIECE WAS MISSING PRIOR TO THE START OF THE CASE. SURGEON SEARCHED FOR THE PIECE THROUGHOUT THE CASE, BUT COULD NOT LOCATE DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9354638 ↗
• MalfunctionOct 25, 2019Loss of Power; Therapeutic or Diagnostic Output Failure

  THE PT WAS UNDERGOING A SURGICAL PROCEDURE, WHEN THE SURGEON WAS USING THE HARMONIC FOCUS SHEARS AND ADAPTIVE TISSUE TECHNOLOGY 9CM. THE INSTRUMENT STOPPED WORKING IN THE MIDDLE OF THE PROCEDURE. IT WAS REMOVED FROM THE STERILE FIELD AND REPLACED SO THE SURGEON COULD CONTINUE. NO HARM NOTED TO THE PT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244404 ↗
• MalfunctionOct 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HAR9F APPEARS TO BE DEFECTIVE. THE WHITE INSULATION PART OF THE HAND PIECE STARTED TO FALL APART IN THE WOUND. THE HARMONIC MACHINE WAS SET AT THE DEFAULT MIN 3 MAX 5. IT TURNED INTO ¿DUST¿ AND THE DOCTOR REMOVED THE VISIBLE PIECES AND IRRIGATED THE WOUND THOROUGHLY. IT WAS A PARATHYROID EXPLORATION. THE SURGEON EXPLORED AND IRRIGATED THE WOUND THOROUGHLY AND THERE WERE NO PIECES OR REMAINING DUST VISIBLE ALTHOUGH HE FELT IT IMPOSSIBLE TO SAY SO WITH 100% CERTAINTY THAT ALL WAS REMOVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL, 5-10 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216553 ↗
• MalfunctionSep 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WHITE TIP FELL OFF OF ONE SIDE OF THE HARMONIC SCALPEL (HAR9F) WHILE IN USE. THE TIP DID NOT FALL INTO THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8961790 ↗
• InjuryApr 3, 2019Energy Output Problem; Failure to Cut; Energy Output Problem; Failure to Cut

  IT WAS REPORTED THE DOCTOR STATED THAT THE DEVICE DID NOT CUT AND CAUTERIZE WELL. A BLOOD VESSEL DID NOT SEAL, SO THEY HAD TO SUTURE IT CLOSED. THERE WAS NO PATIENT INJURY OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480717 ↗
• MalfunctionOct 4, 2018Failure of Device to Self-Test

  DURING THE PROCEDURE, THE PHYSICIAN WAS USING REPROCESSED HARMONIC FOCUS SHEARS. THE HARMONIC DID NOT PASS THE TEST THE FIRST TIME, SO THEY REPLACED THE CORD. IT STILL DID NOT WORK, SO THEY GOT ANOTHER HANDPIECE AND TESTED AGAIN. THE SECOND HANDPIECE DID NOT PASS. A NEW HARMONIC MACHINE WAS RETRIEVED AND BOTH HANDPIECES WERE RETESTED. NEITHER HANDPIECE WORKED WITH THE NEW MACHINE. PHYSICIAN PROCEEDED WITH THE REST OF THE PROCEDURE WITHOUT USING HARMONIC. NO HARM CAME TO THE PATIENT AND THE PROCEDURE WAS FINISHED AS PLANNED. MANUFACTURER RESPONSE FOR SCALPEL, ULTRASONIC, REPROCESSED, N/A (PER SITE REPORTER). THE REP HAS BEEN NOTIFIED AND THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE FOR SCALPEL, ULTRASONIC, REPROCESSED, N/A (PER SITE REPORTER). THE REP HAS BEEN NOTIFIED AND THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933484 ↗
• MalfunctionSep 19, 2018Break; Break

  IT WAS REPORTED FOR A HARMONIC SCALPEL (HAR9F) THAT THE METAL SHEAR BROKE OFF DURING CASE. THE PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITHOUT REQUIRING AN X-RAY NOR LARGER INCISION. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889734 ↗
• MalfunctionJul 24, 2018Break; Break

  IT WAS REPORTED THE TIP OF THE HARMONIC SCALPEL (HAR9F) BROKE OFF TWO HOURS AFTER THE CASE STARTED. THE PIECE WAS RECOVERED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716130 ↗
• MalfunctionJun 21, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED FOR A HARMONIC SCALPEL (HAR9F) THAT THE TEFLON PAD BROKE IN HALF, SPECIFICALLY THE TOP HALF/TIP OF THE TEFLON PAD. IT FELL OFF INTO PATIENT BUT WAS RETRIEVED IMMEDIATELY WITH A GRASPER. THE DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7627049 ↗