AESCULAP FS618SURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964105296), received between Mar 16, 2021 and Feb 15, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO AESCULAP AG THAT AN ORTHOPILOT CAP SINGLE-USE MARKERS (PART # FS618SU) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE NAVIGATION WITH FS100, TKR2, CAP MARKER. NO STABLE VISIBILITY OF THE TIBIA TRANSMITTER. BALLS EXCHANGED, NO IMPROVEMENT. NAVIGATION ABORTED, CONTINUED WITH MANUAL SURGICAL TECHNIQUE. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00017 ((B)(4) - FS618SU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535629 ↗
• InjuryFeb 11, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FS618SU - ORTHOPILOT CAP SINGLE-USE MARKERS. ACCORDING TO THE COMPLAINANT, THE NAVIGATION WITH FS100, TKR2, CAP MARKER. NO STABLE VISIBILITY OF THE TIBIA TRANSMITTER. BALLS EXCHANGED, NO IMPROVEMENT. NAVIGATION ABORTED, CONTINUED WITH MANUAL SURGICAL TECHNIQUE. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00025 (400508185 - FS618SU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515163 ↗
• InjuryDec 10, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO AESCULAP AG THAT AN ORTHOPILOT CAP SINGLE-USE MARKERS (PART # FS618SU) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN. ACCORDING TO THE COMPLAINANT, THERE WAS NO STABLE VISIBILITY OF TRANSMITTER. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975851 ↗
• InjuryMay 19, 2021Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED TO AESCULAP AG THAT AN ORTHOPILOT CAP SINGLE-USE MARKERS (PART # FS618SU) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THERE WAS A LACK OF VISIBILITY OF CAP MARKERS WITH OPI ELITE CAMERA (PART # FS111). AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00402 ((B)(4) FS618SU). 9610612-2021-00403 ((B)(4) FS618SU). INVOLVED COMPONENTS FS111-UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850177 ↗
• InjuryMay 19, 2021Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED TO AESCULAP AG THAT AN ORTHOPILOT CAP SINGLE-USE MARKERS (PART # FS618SU) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THERE WAS A LACK OF VISIBILITY OF CAP MARKERS WITH OPI ELITE CAMERA (PART # FS111). AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4); CC (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00402 ((B)(4) FS618SU), 9610612-2021-00403 ( (B)(4) FS618SU). INVOLVED COMPONENTS: FS111-UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850175 ↗
• MalfunctionMar 16, 2021Misconnection; Product Quality Problem; Misconnection; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FS618SU - ORTHOPILOT CAP SINGLE-USE MARKERS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE USERS REPORTED DURING THE PROCEDURE, THE ORTHOPILOT NO LONGER RECOGNISED THE MARKER. THE MARKER STOPPED WORKING DUE TO THE LACK OF A REFLECTIVE AREA. AS A RESULT OF THIS DEFECT,THE TEAM HAD TO CHANGE THE DETECTOR, CAUSING A SLIGHT DELAY IN THE PROCEDURE. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496723 ↗