VersaStep VS100705Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521082809), received between Jun 20, 2017 and Apr 15, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE TROCAR HAD A BREAKAGE, THE HEAD PART OF THE TROCAR'S DILATOR WAS FOUND NOT TO BE WELDED AND HAD COME OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116676 ↗
• MalfunctionMay 3, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE DEVICE WAS USED WITHOUT ANY PROBLEMS FROM PUNCTURE UNTIL THE PROCEDURE WAS COMPLETED. AFTER THE CASE, A DAMAGE WAS FOUND TO BE THE SEAL OF THE TROCAR AND THE PRODUCT WAS RECEIVED. THE PRODUCT WAS NO LONGER REPLACED SINCE THE SURGERY WAS ALREADY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759995 ↗
• MalfunctionJul 25, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PECTO SEAL PROCEDURE, WHEN THE CAMERA OR GRASPER INSERTING IN TROCAR, THE SEAL WAS TOO TIGHT. INSTRUMENTS ARE VERY HARD TO INSERT. WHEN INSTRUMENTS ARE RETRACTED IT WAS TOO TIGHT AND PULL OUT THE VISA PORT THROUGH THE INCISION ON MULTIPLE OCCASIONS. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 8827847 ↗
• MalfunctionJun 20, 2017Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A GASTRECTOMY PROCEDURE, IT WAS NOTICED THAT THE TOP OF THE PRODUCT (SLEEVE) WAS BROKEN WHEN THE DEVICE WAS UNPACKED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6654084 ↗