NA 03.045.033Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982296153), received between Oct 4, 2022 and Jul 14, 2025 — classified as 3 malfunctions.

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

• MalfunctionJul 14, 2025Material Integrity Problem; Material Integrity Problem

  THE PRODUCT DAMAGE DOCUMENTED HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500599 ↗
• MalfunctionOct 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE EVENT OCCURRED WHERE CHALKY RESIDUE WAS ON ITEMS. TRIED TO WIPE OFF BUT IT SEEMED STAIN. CSPD OF FACILITY WANTED GRAPHIC CASE AND ITEMS REPLACED BEFORE BEING ABLE TO STERILIZE SET. NO ADDITIONAL INFORMATION WAS REPORTED. PATIENT DID NOT EXPERIENCED A POST-OP DEVICE MALFUNCTION. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1) DRIVER FOR NUT THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539999 ↗
• MalfunctionOct 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE EVENT OCCURRED WHERE CHALKY RESIDUE WAS ON ITEMS. TRIED TO WIPE OFF BUT IT SEEMED STAIN. CSPD OF FACILITY WANTED GRAPHIC CASE AND ITEMS REPLACED BEFORE BEING ABLE TO STERILIZE SET. NO ADDITIONAL INFORMATION WAS REPORTED. PATIENT DID NOT EXPERIENCED A POST-OP DEVICE MALFUNCTION. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1) DRIVER FOR NUT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539979 ↗