AESCULAP ER876Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653042449), received between Mar 18, 2021 and Apr 21, 2021 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionApr 21, 2021Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED TO AESCULAP INC. THAT A UTERINE CANNULAE W/2 CONES LGTH 330MM (PART # ER876) DEVICE PROBLEM WAS EXPERIENCED. ACCORDING TO THE COMPLAINANT, THE INSTRUCTIONS FOR USE (IFU) DOCUMENT IS INADEQUATE. THE DEVICE WAS UNABLE TO BE THOROUGHLY CLEANED. RESIDUAL BIOBURDEN WAS FOUND IN THE SHAFT OF THE PROBE AND INSIDE THE CONE. NO PATIENT INVOLVEMENT WAS REPORTED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4) AND UNDER FDA REFERENCE MW5099373. INVOLVED COMPONENTS: ER876201 - CONE SMALL F. ER876 - LOT UNKNOWN, ER876202 - CONE BIG F. ER876 - LOT UNKNOWN, FREMD010 - FOREIGN ARTICLE APG010 - LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703831 ↗
• InjuryMar 18, 2021Disconnection; Material Fragmentation; Separation Problem; Disconnection; Material Fragmentation; Separation Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH ER876 - UTERINE CANNULAE W/2 CONES LGTH 330MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE ACORN TIP OF THE CANNULA DISCONNECTED DURING SURGERY. RETAINED FOREIGN BODY FOLLOWING PROCEDURE. PATIENT HAD AN OUTPATIENT LAPAROSCOPIC LEFT OVARIAN CYSTECTOMY. DURING PROCEDURE A COHEN UTERINE MANIPULATOR WAS USED WITH AN ACORN TOP. DURING THE PROCEDURE THE ACORN TIP BECAME DISCONNECTED FROM THE MANIPULATOR. THIS WAS NOT DETECTED DURING THE PROCEDURE. PATIENT WAS DISPOSITIONED HOME. RETURNED TO PROVIDER CLINIC THE NEXT DAY WITH COMPLAINTS OF VAGINAL FULLNESS. VAGINAL EXAM PERFORMED AND ECORN TIP DISCOVERED AND REMOVED WITH NO HARM TO PATIENT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11516210 ↗
• InjuryMar 18, 2021Disconnection; Separation Problem; Disconnection; Separation Problem

  NO CHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 11516144 ↗