Force FX Force FX-CS (UDI 10884521780576)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521780576), received between Oct 6, 2021 and Jul 21, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  ACCORDING TO THE REPORTER, DURING SURGERY, UNIT HAS COMPONENT LOOSE. THE DOCTOR IN CHARGE CALLED THE NURSE, CLAIMING THAT THE NON-MEDTRONIC SCALPEL PEN HAD BURNED THE OPERATIVE FIELD. HOWEVER, WHEN OBSERVING THE NURSE, SHE SAYS THAT THE PEN WAS ON TOP OF THE OPERATIVE FIELD, RESTING ON THE PATIENT IN THE CHEST REGION, THE PROBLEM OCCURRED AFTER THE DOCTOR FINISHED USING THE EQUIPMENT. THE PATIENT WAS PROTECTED. THE PATIENT DID NOT HAVE ANY DAMAGE RELATED TO THE ADVERSE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374828 ↗
• MalfunctionOct 6, 2021Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AT THE END OF THE SURGERY, THE PATIENT PRESENTED BURNS IN THE FACE AFTER THEY USE THE MONOPOLAR/BIPOLAR ENERGY. THERE WAS INFORMATION THAT THE RETURN PLATE WAS FAR FROM THE SURGERY SITE, THE SURGERY WAS IN THE CERVICAL REGION AND THE RETURN PLATE WAS PLACED ON THE PATIENT'S CALF.

  Patient problems: Burn(s)

  MAUDE report 12587121 ↗