VersaOne B12STSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521539884), received between Apr 3, 2017 and Feb 20, 2025 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE SURGEON WAS HAVING TROUBLE PUTTING DOWN THE CLIP APPLIER DUE TO THE SEAL BEING BROKEN. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421724 ↗
• MalfunctionJul 18, 2022Break; Protective Measures Problem; Break; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE TROCAR BROKE LEAVING THE KNIFE BLADE EXPOSED. THE SURGEON REMOVED THE OBTURATOR TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048019 ↗
• MalfunctionApr 23, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, AT THE BEGINNING OF INSERTION IN THE PERITONEUM, THE DEVICE VALVE BROKE OFF AND THERE WAS A PROBLEM IN THE RETRACTION OF THE TROCAR. THERE WERE BLUE PIECES OF THE TROCAR VALVE IN THE CAVITY OF THE PATIENT AND WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8539695 ↗
• MalfunctionApr 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHILE ON REMOVAL OF THE TROCAR SLEEVE, IT WAS NOTICED THAT A PIECE OF THE TROCAR SLEEVE WAS DEMOLISHED. THE PIECE WAS FOUND BACK IN THE WOUND (IN THE SUBCUTICULAR LAYER OF THE ABDOMINAL WALL) AND WAS RETRIEVED FROM THE PATIENT USING GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492941 ↗
• MalfunctionApr 3, 2017Break; Mechanical Problem; Break; Mechanical Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC PROCEDURE. THE OBTURATOR / TROCAR BROKE. THE BLADE FAILED TO DEPLOY. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, ANOTHER ACCESS PORT WAS USED. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6453996 ↗