Harmonic Focus FCS17Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705036001942), received between Dec 8, 2017 and Mar 15, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE THE TIP BROKE. THE DEVICE WAS REPLACED. THE PROCEDURE WAS DELAYED BY 10 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  MAUDE report 13766552 ↗
• MalfunctionNov 30, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CUTTING & COAGULATION WAS NOT WORKING. THE SURGERY WAS DELAYED BY 15 MINUTES. THE DEVICE WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897023 ↗
• MalfunctionJun 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE THE TIP OF THE ENERGY DEVICE BROKE DURING SURGERY. THE PROCEDURE WAS DELAYED 5 MINUTES. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001329 ↗
• MalfunctionApr 21, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE THE BLADE BROKE. THE SURGERY WAS DELAYED 20 MINUTES BUT IT WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701425 ↗
• MalfunctionJun 27, 2018Break; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN OPEN PROCEDURE FOR THYROID GLAND, ¿TIGHTEN ASSEMBLY¿ WAS DISPLAYED DURING USE. THE DEVICE WAS REASSEMBLED BUT THE DEVICE DID NOT FUNCTION AT ALL. THE ACTIVE BLADE WAS BROKEN OFF OUTSIDE PATIENT WHEN THE DEVICE WAS CLEANED WITH A WET GAUZE. THE DEVICE WAS USED ON THE BLOOD VESSELS. NO PIECES FELL INTO THE PATIENT. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7644353 ↗
• MalfunctionMar 20, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN OPEN PD, ¿TWO SWITCH ACTIVATIONS DETECTED¿ WAS DISPLAYED WHEN THE MAX BUTTON WAS PRESSED. AND THE DEVICE WAS ACTIVATED AUTOMATICALLY THOUGH NO BUTTON WAS PRESSED. THE MIN BUTTON FUNCTIONED PROPERLY. THE DEVICE WAS USED ON THE BLOOD VESSELS. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7355970 ↗
• MalfunctionJan 30, 2018Break

  IT WAS REPORTED THAT DURING AN OPEN HEPATECTOMY PROCEDURE, BLADE TIP WAS BROKEN OFF. ACCORDING TO THE DOCTOR, THE DEVICE MIGHT HAVE CLAMPED THE XIPHOID PROCESS. BUT NO PIECES WERE LEFT INSIDE THE PATIENT. THE BROKEN PIECES OF THE BLADE TIP WERE RETRIEVED AND DISPOSED AT THE OPERATION ROOM. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7227702 ↗
• MalfunctionDec 13, 2017Break; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY, AN UNKNOWN ERROR OCCURRED. THE BLADE TIP WAS BROKEN OFF OUTSIDE THE PATIENT WHEN THE DEVICE WAS WIPED WITH THE GAUZE. GEN11 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7115992 ↗
• MalfunctionDec 8, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS ACTIVATED AUTOMATICALLY THOUGH NEITHER FOOT SWITCH NOR HAND SWITCH WAS PRESSED. THE BLADE TIP WAS NOT BROKEN OFF AND NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7101966 ↗