NA PDL402Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034700557), received between Dec 20, 2016 and Sep 12, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2017Break; Break

  IT WAS REPORTED THAT THE INSERTER-MEDIUM WAS FOUND BROKEN IN THE TRAY WHILE THE CONSULTANT WAS INSPECTING HIS FIELD EQUIPMENT. THIS ISSUE WAS NOT IDENTIFIED IN THE HOSPITAL OR STERILE PROCESSING DEPARTMENT. THE INSERTER WAS FOUND WITH THE CENTRAL ARM BROKEN OFF. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) INSERTER-MEDIUM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6859136 ↗
• MalfunctionMar 6, 2017Break; Break

  THE DEVICE SHAFT WAS NOTED TO BE BROKEN DURING AN INITIAL INSPECTION AND NOTED TO HAVE FALLEN APART. TWO BALL BEARINGS WERE ALSO RETURNED WITH THE BROKEN DEVICE; ONE SMALL, ONE LARGE, TWO SMALL SCREWS AND ONE PIN.

  Patient problems: No Patient Involvement

  MAUDE report 6381699 ↗
• MalfunctionDec 20, 2016Break; Break

  SERVICE AND REPAIR DEPARTMENT DOCUMENTED SYNTHES EVALUATION EQUIPMENT (INSERTER-MEDIUM) FAILED INSPECTION-BROKEN PART-ISSUE IDENTIFIED DURING SERVICE & REPAIR ACTIVITIES OF THE EVALUATION SET. THERE WERE NO ISSUES REPORTED BY THE CUSTOMER. THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6191847 ↗