Harmonic Focus FCS9Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705036001959), received between Dec 21, 2017 and Mar 25, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE WHITE TISSUE PAD COMPLETELY FELL OFF. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED. CHANGED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905293 ↗
• MalfunctionSep 30, 2019Break; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING AN UNKNOWN OPEN PROCEDURE, THE TITANIUM TIP WAS BROKEN. THE BROKEN PIECE WAS 1.5-2MM AND IT'S LOCATION WAS NOT CONFIRMED. THE BLADE TIP WAS BLACK AND CHARRED AND THE OPERATOR HAD NOT HEARD ANY HARSH SOUND. THE DOCTOR "SEARCHED FOR IT IN THE VIEW AND TAKES A C-ARM X-RAY MACHINE." CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. THE PATIENT IS STABLE FOR NOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9137644 ↗
• MalfunctionJan 18, 2019Defective Component

  IT WAS REPORTED THAT DURING AND UNKNOWN PROCEDURE, THE DEVICE WAS NOT ABLE TO LIGATE. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261173 ↗
• MalfunctionJan 16, 2019Device Alarm System

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE GENERATOR ALARMED THAT BLADE PRESSURE NEED TO BE LOW. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8255217 ↗
• MalfunctionNov 8, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ACTIVE BLADE OF THE DEVICE BROKE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051544 ↗
• MalfunctionAug 8, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS BROKEN DURING THE INSTALLATION. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7766039 ↗
• MalfunctionMay 10, 2018Break

  IT WAS REPORTED THAT THE TITANIUM TIP BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISCARDED. THEY CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504358 ↗
• MalfunctionDec 21, 2017Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE, ALERT MESSAGE SHOWN ON THE GENERATOR. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7140386 ↗