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AESCULAP EA323RRecalls & reported problems

Aesculap AG · Purse String Clamp, 11", (280 mm), (60 mm), non-sterile, reusable · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963715984), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (1 report).

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

  • Product Quality Problem1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 3, 2022Product Quality Problem; Product Quality Problem

    IT WAS REPORTED TO AESCULAP AG THAT A PURSE STRING CLAMP 60MM JAW 280MM (PART # EA323R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE INTESTINAL TISSUE CRUSHED DURING SURGERY. THE SURGEON COMPLAINED THAT HE HAD SO MUCH TENSION THAT THE INTESTINAL TISSUE WAS NO LONGER CLAMPED, BUT WAS CRUSHED. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 3, 2022 WHICH REVEALED THAT "DURING ESOPHAGEAL SURGERY, THE ESOPHAGUS SLIPPED OUT OF THE CLAMP." THIS RESULTED IN A PROCEDUREAL DELAY OF APPROXIMATELY FIFTEEN (15) MINUTES. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT HARM IS CURRENTLY UNKNOWN. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

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

    MAUDE report 13443953 ↗

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