GYRUS ACMI 5711012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925010772), received between Nov 8, 2022 and Nov 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Packaging 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2022Packaging Problem; Packaging Problem

  OLYMPUS (OEKG) WAS INFORMED BY QUALITY ASSURANCE SPECIALIST AT THE USER FACILITY THAT THE CUSTOMER RECEIVED THE SUR-CATCH HELICAL BASKET WHICH ¿APPEARED TO HAVE MOULDING DEFECTS DURING PACKING FROM THE FACTORY¿. THE CUSTOMER PROBLEM WAS FOUND DURING A RECEIPT INSPECTION. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756997 ↗
• MalfunctionNov 8, 2022Packaging Problem; Packaging Problem

  OLYMPUS (OEKG) WAS INFORMED BY QUALITY ASSURANCE SPECIALIST AT THE USER FACILITY THAT THE CUSTOMER RECEIVED THE SUR-CATCH HELICAL BASKET WHICH ¿APPEARED TO HAVE MOULDING DEFECTS DURING PACKING FROM THE FACTORY¿. THE CUSTOMER PROBLEM WAS FOUND DURING A RECEIPT INSPECTION. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756840 ↗