n.a. 30173RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551008898), received between Mar 2, 2020 and Aug 13, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237264 ↗
• MalfunctionMar 2, 2020Material Separation; Material Separation

  ALLEGEDLY, PER THE CUSTOMER DURING A BARIATRIC PROCEDURE THE SURGEON COULD NOT GRAB THE NEEDLE, WHILE INSPECTING THE NEEDLE DRIVER HE NOTICED THE CARBIDE INSERT ON ONE OF THE JAWS MISSING. PER THE FACILITY IT WAS UNCERTAIN IF THE METAL INSERT WAS ON THE JAW IN THE BEGINNING OF THE PROCEDURE. A SEARCH FOR THE METAL CARBIDE INSERT INSIDE THE PATIENT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING ANOTHER SET, WITH NO FURTHER INTERVENTION REQUIRED OR HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774935 ↗