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SCALPFIX FF012RRecalls & reported problems

Aesculap AG · SCALPFIX APPLICATOR · 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 04038653222841), received between Mar 10, 2021 and Mar 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Ejection 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

  • Ejection Problem1

Patient problems

  • 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.

  • MalfunctionMar 10, 2021Ejection Problem; Ejection Problem

    IT WAS REPORTED TO AESCULAP INC. THAT A SCALPFIX APPLICATOR (PART # FF012R) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE CARTRIDGES WERE NOT EJECTING AND ONE OF THE PRONGS WAS FOUND TO BE BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11457001 ↗

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