NA 5407010272Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327135558), received between Sep 19, 2022 and Sep 19, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Collapse” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2022Collapse; Material Disintegration; Collapse; Material Disintegration

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE CLIP APPEARED SMASHED DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451076 ↗
• MalfunctionSep 19, 2022Collapse; Material Disintegration; Collapse; Material Disintegration

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE CLIP APPEARED SMASHED DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451046 ↗
• MalfunctionSep 19, 2022Collapse; Material Disintegration; Collapse; Material Disintegration

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE CLIP APPEARED SMASHED DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451041 ↗
• MalfunctionSep 19, 2022Collapse; Material Disintegration; Collapse; Material Disintegration

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE CLIP APPEARED SMASHED DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451003 ↗
• MalfunctionSep 19, 2022Collapse; Material Disintegration; Collapse; Material Disintegration

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE CLIP APPEARED SMASHED DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15450900 ↗
• MalfunctionSep 19, 2022Collapse; Material Disintegration; Collapse; Material Disintegration

  THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE CLIP APPEARED SMASHED DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15450860 ↗