N/A 6790-100-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327304251), received between Jan 8, 2019 and May 3, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 18, 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.

• MalfunctionMay 3, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  THE USER FACILITY REPORTED THAT DURING PREPARATION FOR A PROCEDURE, FOREIGN MATERIAL WAS FOUND IN THE STERILIZED PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE. THERE WAS PATIENT INVOLVEMENT, NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14268961 ↗
• MalfunctionJan 8, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THE USER FACILITY REPORTED THAT DURING UNBOXING THE DEVICE STERILE PACKAGING WAS FOUND TO BE UNSEALED, POSING THE RISK OF EXPOSURE TO EXCESSIVE PATHOGENS. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 8226334 ↗