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AESCULAP ER402RRecalls & reported problems

Aesculap AG · SIMS Uterine Curette, 10", (255 mm), rigid, sharp, Fig. 2, width: 8,500 mm, non-sterile, reusable · Class 1

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 04038653042081), received between Aug 15, 2023 and Aug 15, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation2

Patient problems

  • 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.

  • InjuryAug 15, 2023Material Fragmentation; Material Fragmentation

    INVESTIGATION COMPLETE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17548923 ↗
  • InjuryAug 15, 2023Material Fragmentation; Material Fragmentation

    IT WAS REPORTED TO AESCULAP AG THAT A SIMS UTERINE CURETTE #2 SHARP 255MM (MATERIAL # ER402R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6), 2023. ACCORDING TO THE COMPLAINT DESCRIPTION, THE WELD BROKE NEAR THE DISTAL END AT THE WORKING END AND NEEDED TO BE RETRIEVED FROM ABDOMINAL AREA. FOLLOWING THE RETRIEVAL, THE AREA WAS SCANNED TO VERIFY THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT. ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THIS EVENT PROLONGED THE SURGERY WITH 45 MINUTES. ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 17548919 ↗

Other CURETTE, UTERINE devices

All CURETTE, UTERINE devices →

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