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AESCULAP PF010ARecalls & reported problems

Aesculap AG · PAEDISCOPE FLEXIBLE SCOPE · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653320547), received between Sep 27, 2021 and Sep 27, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 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

Device problems

  • Mechanical Problem2
  • Display or Visual Feedback Problem1
  • Optical Problem1

Patient problems

  • Insufficient Information2
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • InjurySep 27, 2021Mechanical Problem; Optical Problem; Mechanical Problem; Optical Problem

    THE ARTICLE CODE OF THE DEVICE CHANGED TO PF011A - PAEDISCOPE EYEPIECE AND DUE TO ADDITIONAL INFORMATION RECEIVED THE PATIENT HARM CHANGED TO SURGERY DELAY.

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

    MAUDE report 12536365 ↗
  • InjurySep 27, 2021Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PF010A-PAEDISCOPE FLEXIBLE SCOPE. ACCORDING TO THE COMPLAINT DESCRIPTION,DURING CYST FENESTRATION PROCEDURE THERE WAS AN SURGERY DELAY DUE TO THAT VERY POOR OR NO IMAGE CAME THROUGH THE SCOPE. LIGHT SOURCE APPEARED TO BE FULLY OPERATIONAL. HOWEVER, WHEN SCOPE WAS ATTACHED TO THE CAMERA, THERE WAS NO VISABLE IMAGE. THE IMAGE THAT CAME THROUGH WAS DARK, AND SURGEON WAS NOT ABLE TO PROCEED WITH THE CASE. THE PATIENT WAS UNDER ANESTHESIA. INCIDENT CAUSED SURGEON TO STOP THE CASE AND RESCHEDULE FOR ANOTHER PROCEDURAL DATE. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC: (B)(4).

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

    MAUDE report 12536140 ↗

Other ENDOSCOPE, NEUROLOGICAL devices

All ENDOSCOPE, NEUROLOGICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.