VersaOne RC8STSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521784024), received between Feb 9, 2023 and Oct 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K201805); they may or may not involve this specific model.

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.

Recalls naming this device

1. Mar 22, 2023Open, Classified

   There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.

   Z-1463-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Difficult to Insert; Noise, Audible; Difficult to Insert; Noise, Audible

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN ATTEMPTING TO INSERT THE INTERNAL CYLINDER UNIT TO THE CANNULA, THE INTERNAL CYLINDER UNIT BECAME STUCK AND COULD NOT MOVE AFTER PASSING THROUGH THE SEAL. BOTH INSERTION AND REMOVAL WERE IMPOSSIBLE. THERE WAS ALSO AN ABNORMAL SOUND COMING FROM THE DEVICE. A MEDICAL PROFESSIONAL WHO PREPARED THE DEVICE APPLIED SIGNIFICANT FORCE TO REMOVE IT FROM THE CANNULA. ANOTHER INTERNAL CYLINDER UNIT WAS BROUGHT IN AND INSERTED INTO THE CANNULA, THE INTERNAL CYLINDER UNIT PASSED THROUGH WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494768 ↗
• MalfunctionFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY WITH LYMPH NODE DISSECTION, THERE WAS A SMALL PRESSURE MARK (ABOUT 1.5 CM * 0.5CM, RED, SKIN NOT OPEN) FROM TROCAR IN PATIENT SKIN BECAUSE OF TROCAR PLACEMENTS IN THE PATIENT ABDOMEN (PORT PLACEMENT).

  Patient problems: Erythema

  MAUDE report 16333837 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201805. One submission often covers many models, so check the product and lot details in each record.

• Z-1464-2023 · Mar 22, 2023 · Open, Classified
  VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
• Z-1465-2023 · Mar 22, 2023 · Open, Classified
  VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS