NA 397.41Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587041544), received between Jan 7, 2021 and Jan 7, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 7, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE SURGEON REQUESTED REPLACEMENTS FOR PARTS BECAUSE THE PARTS WERE NO LONGER SHARP ENOUGH AND NOT WORKING WELL. THIS REPORT INVOLVES ONE (1) 2.0MM TROCAR WITH HANDLE & OBTURATOR. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11134900 ↗
• MalfunctionJan 7, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE SURGEON REQUESTED REPLACEMENTS FOR PARTS BECAUSE THE PARTS WERE NO LONGER SHARP ENOUGH AND NOT WORKING WELL. THIS REPORT INVOLVES ONE (1) 2.0MM TROCAR WITH HANDLE & OBTURATOR. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11134711 ↗
• MalfunctionJan 7, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE SURGEON REQUESTED REPLACEMENTS FOR PARTS BECAUSE THE PARTS WERE NO LONGER SHARP ENOUGH AND NOT WORKING WELL. THIS REPORT INVOLVES ONE (1) 2.0MM TROCAR WITH HANDLE & OBTURATOR. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11134058 ↗