Harmonic HAR17FRecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705036014737), received between Jan 9, 2018 and May 5, 2026 — classified as 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Material Separation

  IT WAS REPORTED THAT DURING A HEAD AND NECK SURGERY PERFORMED BY THE DR., MIDWAY THROUGH THE NECK DISSECTION, ONE OF THE JAWS OF THE FOCUS DETACHED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082516 ↗
• MalfunctionApr 9, 2026Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS BREAKAGE OF THE METAL JAW DURING USE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830715 ↗
• MalfunctionMar 4, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS NOT WORKING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512045 ↗
• MalfunctionOct 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT SCHEDULED FOR OPEN-ROUTE EXTENDED RIGHT HEPATECTOMY, IN WHICH THE SURGEON REQUESTED A 17 CM HARMONICA FOCUS LONG CLAMP IN HIS SPECIAL SUPPLIES. AT THE TIME OF USE IN THE LIVER SECTION, THE TIP OF THE HARMONIC WAS DIVIDED IN TWO, SO IT STOPPED WORKING. THE SURGEON REQUESTED TO REPLACE IT WITH ANOTHER CLAMP, AS THE PROCEDURE WAS STILL TO BE FINISHED AND, WITHOUT A TIP, THE CLAMP DOES NOT WORK PROPERLY AND CAN BE DANGEROUS FOR THE PATIENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265587 ↗
• MalfunctionSep 8, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A COLECTOMY, AFTER OPEN PRODUCT FROM PACKAGING AND USE IT, THE PRODUCT WAS NOT WORKING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994970 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DR. PERFORMS A CHOLECYSTECTOMY AND EMPTYING OF HYLIOHEPATIC NODES. THEN, TWO-SEGMENT OPEN-ROUTE HEPATECTOMY IS PERFORMED WITH ULTRASONIC ASPIRATOR (SONOCA). THE DEVICE IS ALSO USED; INITIALLY ONE IS PASSED, BUT THE DR. USES IT TWICE AND A BROKEN WHITE TIP IS EVIDENT. DR. REPORTS THAT THE CLAMP CAN NO LONGER BE USED AS IT AFFECTS PATIENT SAFETY. PHARMACY IS INFORMED AND A NEW HARMONIC FOCUS LONG IS PASSED. THE FIRST ONE IS WASHED AND SAVED TO PREPARE THE REPORT ON THE PLATFORM. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777374 ↗
• MalfunctionJul 17, 2025Self-Activation or Keying; Failure to Read Input Signal; Activation, Positioning or Separation Problem; Self-Activation or Keying; Failure to Read Input Signal; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ENERGY TRANSMIT OF OPEN HARMONIC WAS NOT STABLE (PROLONGED CUTTING) AND THEN SHOWED HIGH BLADE PRESSURE ALARM. THEY CHANGE A NEW DEVICE FOR PREVENTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531074 ↗
• MalfunctionDec 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DURING CLEANING, THE UPPER PART OF THE JAW, PAD, BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846071 ↗
• MalfunctionNov 22, 2024Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SUPPLIER DELIVERED MEDICAL PRODUCTS TO THE CLINIC IN PRIMARY PACKAGING WITHOUT SECONDARY CARDBOARD. THE PRIMARY PACKAGING HAS SIGNS OF CREASING, THERE IS A SUSPICION OF A VIOLATION OF THE STERILITY OF THE MEDICAL PRODUCT. IT WAS DISCOVERED THAT THESE MEDICAL PRODUCTS WERE PURCHASED THROUGH PARALLEL IMPORT. THE PURCHASE OF MEDICAL PRODUCTS WAS CARRIED OUT THROUGH THE STATE PROCUREMENT PORTAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20764749 ↗
• MalfunctionNov 22, 2024Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SUPPLIER DELIVERED MEDICAL PRODUCTS TO THE CLINIC IN PRIMARY PACKAGING WITHOUT SECONDARY CARDBOARD. THE PRIMARY PACKAGING HAS SIGNS OF CREASING, THERE IS A SUSPICION OF A VIOLATION OF THE STERILITY OF THE MEDICAL PRODUCT. IT WAS DISCOVERED THAT THESE MEDICAL PRODUCTS WERE PURCHASED THROUGH PARALLEL IMPORT. THE PURCHASE OF MEDICAL PRODUCTS WAS CARRIED OUT THROUGH THE STATE PROCUREMENT PORTAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20762510 ↗
• MalfunctionNov 22, 2024Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SUPPLIER DELIVERED MEDICAL PRODUCTS TO THE CLINIC IN PRIMARY PACKAGING WITHOUT SECONDARY CARDBOARD. THE PRIMARY PACKAGING HAS SIGNS OF CREASING, THERE IS A SUSPICION OF A VIOLATION OF THE STERILITY OF THE MEDICAL PRODUCT. IT WAS DISCOVERED THAT THESE MEDICAL PRODUCTS WERE PURCHASED THROUGH PARALLEL IMPORT. THE PURCHASE OF MEDICAL PRODUCTS WAS CARRIED OUT THROUGH THE STATE PROCUREMENT PORTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761656 ↗
• MalfunctionNov 22, 2024Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SUPPLIER DELIVERED MEDICAL PRODUCTS TO THE CLINIC IN PRIMARY PACKAGING WITHOUT SECONDARY CARDBOARD. THE PRIMARY PACKAGING HAS SIGNS OF CREASING, THERE IS A SUSPICION OF A VIOLATION OF THE STERILITY OF THE MEDICAL PRODUCT. IT WAS DISCOVERED THAT THESE MEDICAL PRODUCTS WERE PURCHASED THROUGH PARALLEL IMPORT. THE PURCHASE OF MEDICAL PRODUCTS WAS CARRIED OUT THROUGH THE STATE PROCUREMENT PORTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761639 ↗
• MalfunctionNov 22, 2024Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SUPPLIER DELIVERED MEDICAL PRODUCTS TO THE CLINIC IN PRIMARY PACKAGING WITHOUT SECONDARY CARDBOARD. THE PRIMARY PACKAGING HAS SIGNS OF CREASING, THERE IS A SUSPICION OF A VIOLATION OF THE STERILITY OF THE MEDICAL PRODUCT. IT WAS DISCOVERED THAT THESE MEDICAL PRODUCTS WERE PURCHASED THROUGH PARALLEL IMPORT. THE PURCHASE OF MEDICAL PRODUCTS WAS CARRIED OUT THROUGH THE STATE PROCUREMENT PORTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761434 ↗
• MalfunctionNov 22, 2024Delivered as Unsterile Product; No Apparent Adverse Event; Delivered as Unsterile Product; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SUPPLIER DELIVERED MEDICAL PRODUCTS TO THE CLINIC IN PRIMARY PACKAGING WITHOUT SECONDARY CARDBOARD. THE PRIMARY PACKAGING HAS SIGNS OF CREASING, THERE IS A SUSPICION OF A VIOLATION OF THE STERILITY OF THE MEDICAL PRODUCT. IT WAS DISCOVERED THAT THESE MEDICAL PRODUCTS WERE PURCHASED THROUGH PARALLEL IMPORT. THE PURCHASE OF MEDICAL PRODUCTS WAS CARRIED OUT THROUGH THE STATE PROCUREMENT PORTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761238 ↗
• MalfunctionNov 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, DURING THE INTERVENTION, THE JAW BROKE. THE FRAGMENT WAS RETRIEVED. THE ISSUE LED TO A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746066 ↗
• MalfunctionAug 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE HANDLE WAS BROKEN DURING OPEN GASTRECTOMY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035953 ↗
• MalfunctionApr 23, 2024Material Separation; Failure to Read Input Signal; Material Separation; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE GEN11'S SCREEN SHOWED "RELAX PRESSURE ON BLADE"', AFTER REACTIVATING INSTRUMENT TO CONTINUE, THE SITUATION CONTINUED. A NEW HAR17F WAS SUBSTITUTED TO COMPLETE SURGERY. BLADE WAS BROKEN WHEN CLEANING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163739 ↗
• MalfunctionApr 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HEPATECTOMY THE SURGERY BEGINS AND AFTER 10 MINUTES OF USE THE ACTIVE BLADE BREAKS. THE PROCEDURE WAS DELAYED 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110758 ↗
• MalfunctionApr 8, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A COLECTOMY THE DEVICE ERRORED, CANNOT BE USE ANYMORE. WHEN SURGEON ACTIVE, GEN11 GENERATOR DISPLAYS WARNING: "RESTART GENERATOR." THE PROCEDURE WAS DELAYED 30 MINUTES. THE DEVICE WAS REPLACED WITH A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061691 ↗
• MalfunctionApr 4, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE BROKEN AT THE TIME OF SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043652 ↗
• MalfunctionApr 4, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE BROKEN AT THE TIME OF SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043573 ↗
• MalfunctionMar 22, 2024Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT DURING A GENERAL SURGERY THE DEVICE DIDN'T WORK AND GOT STUCK IN HPBLUE. IT COULDN'T BE DISENGAGED FROM THE HANDPIECE. THE DOCTOR HAD TO USE A NEW HANDPIECE AND HAR17F. THE STUCK HAR17F GOT DISENGAGED AFTER MULTIPLE EFFORTS. THE PROCEDURE WAS DELAYED 10 MINUTES BUT WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961028 ↗
• MalfunctionFeb 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE BLADE WAS BROKEN WHEN THE DEVICE WAS USED ON MUSCLE. NO PIECES WERE LEFT INSIDE THE PATIENT. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758807 ↗
• MalfunctionFeb 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE THE FOCUS LONG WAS BROKEN. THE TIP WAS BROKEN, ONE OF THE BLADES CAME OFF WITHOUT HARMING THE PATIENT. FOCUS DAMAGE IS REMOVED FROM SURGERY. REMOVED FOCUS AND OPEN A NEW ONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711212 ↗
• MalfunctionJan 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE DEVICE HAD ITS BLADE BROKEN DURING BREAST RECONSTRUCTION SURGERY. THE BLADE BROKE AFTER 30 MINUTES OF USE. DURING THE SURGERY, NO INSTRUMENT OR HARD MATERIALS OTHER THAN TISSUE WERE COLLIDED. THE PROCEDURE WAS DELAYED 5 MINUTES WHILE THE DEVICE WAS REPLACED WITH A NEW HARMONIC LONG FOCUS+. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605483 ↗