Harmonic HPBLUERecalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 20705036002151), received between Dec 12, 2017 and Jun 11, 2026 — classified as 7 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (48 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 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE BLUE HANDPIECE DID NOT WORKED. WHEN THE HANDPIECE WAS CHANGED THE DEVICE WORKED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469701 ↗
• MalfunctionJun 11, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE HPBLUE GAVE ERRORS. BY TESTING THE DEVICE IT SEEMS TO BE DEFECT WHILE IT STILL HAS 29 REMAINING USES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469502 ↗
• MalfunctionMar 16, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A CABG, WHILE ASSEMBLING WITH SINGLE USE DEVICE, IT "WOULD NOT WORK." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605788 ↗
• MalfunctionMar 16, 2026Activation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BLUE HAND PIECE IS BROKEN. IT REQUIRES TO MAKE THE TEST AGAIN AND AGAIN. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605726 ↗
• MalfunctionDec 24, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A REPLACE INSTRUMENT ERROR MESSAGE. THERE WAS NO PATIENT CONSEQUENCES IDENTIFIED WHEN THIS COMPLAINT EVENT WAS CAPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887911 ↗
• MalfunctionNov 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO EVENT DETAILS. ATTEMPTS WERE MADE TO OBTAIN DETAILS AND NO INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536290 ↗
• MalfunctionAug 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS NOT WORKING. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861793 ↗
• MalfunctionMay 6, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE OVERHEATS ABNORMALLY WHEN USED. IT WAS SEEN WITH THE UROLOGY OPERATING ROOM. THE FORCEPS HAVE 33 USES REMAINING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971342 ↗
• MalfunctionApr 23, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE ARE STILL 25 TIMES LEFT TO USE BUT HAND PIECE DIDN'T WORKED. THEY TRIED TO USE IT SEVERAL TIMES BUT NOT WORKING. THE PROCEDURE WAS DELAYED 10 MINUTES BUT WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892167 ↗
• MalfunctionMar 26, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS NOT RECOGNIZED. NO PIECES WERE FELL INTO THE PATIENT. 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 21698119 ↗
• MalfunctionMar 3, 2025Failure to Read Input Signal; Difficult or Delayed Activation; Failure to Read Input Signal; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A HPBLUE FAILURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21506349 ↗
• MalfunctionFeb 5, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AN ERROR MESSAGED SHOWED: "REACTIVATE. TWO SWITCH ACTIVATIONS DETECTED: MANUAL CONTROL, REACTIVATE INSTRUMENT TO CONTINUE." THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314562 ↗
• MalfunctionFeb 5, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE OR NURSE TRIED CONNECTING A HARMONIC TO THE BLUE HANDPIECE AND AN ERROR MESSAGE SHOWED: REPLACE HANDPIECE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314546 ↗
• MalfunctionFeb 4, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING A TRAUMA PROCEDURE, WHEN USING THE DEVICE, THERE HAD BEEN A VERY LOUD VOICE IN HAND PIECE. THEY CAN NOT EXPLAIN IT BETTER BUT VERY UNNORMAL SOUND. STILL 46 USING TIMES LEFT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306057 ↗
• MalfunctionFeb 4, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A DEFECTIVE HAND-PIECE. 40 USES REMAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304947 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IT WAS FOUND THAT THE HANDPIECE SCREW IS DAMAGED AT THE TIP BEFORE USE ON PATIENT DURING PHYSICAL INSPECTION. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20896232 ↗
• MalfunctionDec 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A THYROIDECTOMY THERE WAS A DEFECTIVE DEVICE - THE CABLE DOESN'T WORK ANYMORE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20885616 ↗
• MalfunctionOct 21, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HAND PIECE ANNOUNCED ERROR DURING GETTING TOGETHER WITH INSTRUMENT BUT WITH USING TESTING STICK NO PROBLEM FIRST AND SECOND TIME BUT THIRD TIME ANNOUNCE ERROR - REPLACE HAND PIECE. COSTUMER USE SEVERAL NEW INSTRUMENTS. HAND PIECE HAVE 30 USAGES YET. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493085 ↗
• MalfunctionSep 20, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WASN'T ABLE TO SEAL AND CUT. THERE WERE NO VISIBLE ISSUES. THE HANDPIECE HAD 7 USES LEFT. THE DISPOSABLE AND HANDPIECE WERE REPLACED AND IT WORKED FINE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266096 ↗
• MalfunctionSep 4, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HANDPIECE DID NOT WORK ANYMORE, WHILE THERE ARE MORE THAN 90 USES LEFT ON ONE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136023 ↗
• MalfunctionAug 5, 2024Crack; Failure to Read Input Signal; Connection Problem; Crack; Failure to Read Input Signal; Connection Problem

  IT WAS REPORTED THAT DURING A THYROIDECTOMY THE SURGEON WAS USING THIS HPBLUE WITH HAR9F AT FIRST WHICH IT WENT WELL. SUDDENLY THE HAR9F COULD NOT BE ACTIVATED. THUS HE DECIDED TO CHANGE ANOTHER CABLE WITH THE SAME HAR9F TO CONTINUE THE SURGERY. THE PROCEDURE WAS DELAYED. THE NURSE TRIED TO USE THIS CABLE WITH THE SAME HAR9F AFTER CASE, WHICH GIVING SAME ERROR MESSAGE. SALESMAN WENT ON-SITE TO CHECK THE CABLE AND FOUND THERE'S ABNORMAL SITUATION WITH THE CABLE. THE 7 PINS WHERE TO CONNECT WITH ADAPTER GO DARKEN (LOOK LIKE COVERING WITH BLACK DUST) WHICH IS DIFFERENT FROM THE SHINNY PINS WE USUALLY SEE WITH CABLE. SALESMAN ALSO FOUND THERE'S A BLACK METALLIC/PLASTIC FRAGMENT AT THE CONNECTING AREA WITH CONSUMABLES. SALESMAN TRIED TO CONNECT IT WITH GEN11 AND UNDERWENT HANDPIECE TESTING, HOWEVER IT POPPED OUT WITH 'REACTIVE' 'TWO SWITCH ACTIVATING DETECTED' AND COULD NOT PASS THE TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911495 ↗
• MalfunctionJun 25, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CUSTOMERS HPBLUE/HAR9F IS NOT PASSING THE ACTIVATION TEST. REP SAID THE CUSTOMER TRIED MULTIPLE GENERATORS WITH SAME HANDPIECE AND 2 HAR9F DEVICES AND COULD NOT GET EITHER TO ADVANCE PAST THE ACTIVATION SCREEN. CHECKED THE HANDPIECE THEY REPORTED AN ISSUE WITH AND THE CONTACT RING IS FILTHY WHICH MAY BE THE PROBLEM. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609857 ↗
• MalfunctionJun 21, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN ENT PROCEDURE THAT THE FIRST HARMONIC WAS NOT SEALING PROPERLY. A SECOND HARMONIC WAS OPENED AND THE GENERATOR GAVE THE ERROR TO REPOSITION JAWS. THE HANDPIECE AND GENERATOR WAS REPLACED BUT THE ISSUE STILL PERSISTED. A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582826 ↗
• MalfunctionJun 7, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A THYROIDECTOMY AFTER CAREFUL SETUP IT WORKS THEN ERROR MESSAGES KEEP COMING UP - TO TIGHTEN THE HAND PIECE - WHICH THE STAFF DO AND THEN IT WORKS FOR A WHILE AND THEN FURTHER ERROR MESSAGES COME UP. 80 USES REMAINING. ANOTHER HANDPIECE OPENED THE PROCEDURE WAS DELAYED BUT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491344 ↗
• MalfunctionJun 7, 2024Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS IN ERROR MODE.NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490727 ↗