VersaStep VS070000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521093604), received between Jul 22, 2019 and Jul 17, 2024 — 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.

• MalfunctionJul 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE OBTURATOR RAPTURED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO P ATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760803 ↗
• MalfunctionNov 16, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GENERAL LAPAROSCOPY, ON TROCAR PLACEMENT, THE PLASTIC O RING FROM ONE OF THE FIVE TROCARS FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED BY A LAPAROSCOPIC GRASPER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820796 ↗
• MalfunctionJul 22, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, WHILE INSERTING THE RADIAL EXPANDING SLEEVE THROUGH THE ABDOMINAL WALL, THE INSUFFLATION NEEDLE. WHEN THE NEEDLE WAS RETRACTED IT BROKE AND THE WHOLE SLEEVE AND IT WAS REMOVED FOR THE INCISION. ANOTHER SURGINEEDLE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813345 ↗