CONVERTORS 9349Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885380062261), received between May 18, 2021 and May 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 16, 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.

• MalfunctionMay 18, 2021Delivered as Unsterile Product; Physical Resistance/Sticking

  WHILE OPENING TO THE BACK SURGICAL TABLE, SCRUB TECH NOTICED THAT THE OUTSIDE PACKAGING, OF THE CONVERTORS GENERAL PURPOSE STERILE THREE-QUARTER DRAPE, WAS STUCK TO THE INSIDE STERILE WRAPPING. AS IT WAS OPENED, IT RIPPED THE INSIDE WRAPPING MAKING IT NO LONGER STERILE.

  Patient problems: Insufficient Information

  MAUDE report 11841001 ↗