ELITE 2522-28-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295128601), received between Aug 31, 2020 and Aug 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 31, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. BEFORE THE SURGERY, THE HOSPITAL STAFF STERILIZED THE DEVICES BY CLEANING AND DRYING WITH A MACHINE. IT WAS REPORTED THAT AFTER STERILIZATION, THE STAFF SET OUT THE DEVICES FOR THE SURGERY, AND HE/SHE FOUND THAT WATER REMAINED IN THE 9 TRIAL HEADS WHEN HE/SHE PULLED OUT THE DEVICES FROM THE CASE. HE/SHE HAD CHECKED THAT THERE WAS NO WATER IN THE TRIAL HEADS WHEN SET THEM IN THE DRYING MACHINE. THE STAFF JUDGED POOR STERILIZATION BECAUSE WATER WAS REMAINED IN THE DEVICES DESPITE STERILIZED BY AUTOCLAVE, AND HE/SHE STERILIZED THE DEVICES AGAIN. PREVENTING A RECURRENCE OF WATER¿S REMAINING, THE TRIAL HEADS WERE STERILIZED INTO SMALL GROUPS. THE REMAINING OF WATER WAS FOUND AT THE LAST MINUTE OF THE SURGERY, BUT BARELY MADE USING IN THE SURGERY. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10473183 ↗