AESCULAP PV010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046955206742), received between Mar 10, 2021 and Jun 28, 2021 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

3 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 13, 2024Open, Classified

   Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safety mechanism.

   Z-2139-2024 · Root cause: Process control · FDA record ↗

2. Jul 14, 2022Terminated

   Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:

   Z-1516-2022 · Root cause: Software design · FDA record ↗

3. Feb 19, 2021Completed

   Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.

   Z-1409-2022 · Root cause: Material/Component Contamination · FDA record ↗

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.

• InjuryJun 28, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PV010 - AESCULAP AEOS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE AESCULAP AEOS SOFTWARE CRASHED AFTER BEING DRAPED AND WHEN READY TO BE PUSHED IN FOR SURGERY. AFTER MULTIPLE REBOOT ATTEMPTS AND HARD RESTARTS TO THE ENTIRE AEOS SYSTEM, THE SURGEON DECIDED TO USE THE TRADITIONAL MICROSCOPE. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THIS OCCURRED DURING THE BEGINNING OF AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE; THE PATIENT WAS UNDER ANESTHESIA AND THE INITIAL INCISION HAD BEEN MADE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12079265 ↗
• InjuryJun 28, 2021Operating System Becomes Nonfunctional; Unexpected Shutdown; Operating System Becomes Nonfunctional; Unexpected Shutdown

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PV010 - AESCULAP AEOS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE AESCULAP AEOS SOFTWARE CRASHED AFTER BEING DRAPED AND WHEN READY TO BE PUSHED IN FOR SURGERY. AFTER MULTIPLE REBOOT ATTEMPTS AND HARD RESTARTS TO THE ENTIRE AEOS SYSTEM, THE SURGEON DECIDED TO USE THE TRADITIONAL MICROSCOPE. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THIS OCCURRED DURING THE BEGINNING OF AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE; THE PATIENT WAS UNDER ANESTHESIA AND THE INITIAL INCISION HAD BEEN MADE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076969 ↗
• MalfunctionApr 20, 2021Reset Problem; Reset Problem

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00322 (400508474 PV010), 9610612-2021-00323 (400508475 PV010).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697540 ↗
• MalfunctionApr 20, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00322 (400508474 PV010), 9610612-2021-00323 (400508475 PV010).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697539 ↗
• MalfunctionApr 20, 2021Computer Software Problem; Computer Software Problem

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00321 (400508468 PV010), 9610612-2021-00323 (400508475 PV010).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697538 ↗
• MalfunctionApr 7, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO AESCULAP INC. THAT A AESCULAP AEOS (PART # PV010) WAS BEING SETUP FOR PRODUCT DISPLAY. ACCORDING TO THE COMPLAINANT, THE AEOS UNIT WAS SETUP IN A HOTEL CONFERENCE CENTER TO DISPLAY TO LOCAL SURGEONS. REPORTEDLY, DURING SETUP TWO (2) HARDWARE ISSUES WERE OBSERVED: THE WHEEL OF THE SYSTEM WAS BROKEN; RIGHT HAND CONTROL WAS LOOSE. NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00275 ((B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628140 ↗
• MalfunctionApr 7, 2021Break; Loose or Intermittent Connection

  IT WAS REPORTED TO AESCULAP INC. THAT A AESCULAP AEOS (PART # PV010) WAS BEING SETUP FOR PRODUCT DISPLAY. ACCORDING TO THE COMPLAINANT, THE AEOS UNIT WAS SETUP IN A HOTEL CONFERENCE CENTER TO DISPLAY TO LOCAL SURGEONS. REPORTEDLY, DURING SETUP TWO (2) HARDWARE ISSUES WERE OBSERVED: THE WHEEL OF THE SYSTEM WAS BROKEN. RIGHT HAND CONTROL WAS LOOSE. NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00276 ((B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628042 ↗
• MalfunctionMar 10, 2021Computer Software Problem; Mechanical Problem; Computer Software Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PV010 - AESCULAP AEOS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE AEOS SYSTEM GENERATED REBALANCE (20 SECONDS) HAPPENS EVERY TIME AEOS IS MOVED INTO "DRAPE" OR "DRAPE STANDBY." IN THE PAST, THE LONGER REBALANCE WOULD ONLY OCCUR WHEN THE SYSTEM WAS INITIALLY MOVED INTO "DRAPE" POSITION. THE LONGER REBALANCE ESPECIALLY WHEN BRINGING THE SYSTEM INTO SURGERY CAUSES A DELAY UNTIL THE SYSTEM COMPLETES THE ACTION. THE DOCTOR COMPLETED THE CASE WITH AEOS AND THE PATIENT WOKE UP FROM ANESTHESIA NORMALLY. THERE WAS NO DESCRIBED PATIENT HARM. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457003 ↗