VersaOne NONB12SHFRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521546905), received between May 5, 2017 and Feb 26, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTAL RESECTION SURGERY, AT THE TIME OF PERIRECTAL RESECTION AND WHEN THE 5MM FORCEPS WERE INSERTED, THE SEAL BROKE AND THERE WAS PNEUMOPERITONEUM LEAKAGE. A NEW DEVICE WAS TAKEN OUT AND USED ONLY THE CAP OF THE OUTER CANNULA TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777621 ↗
• MalfunctionJan 3, 2024Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RECTAL RESECTION, WHILE ON RESECTION THE SURROUNDINGS OF RECTUM, THERE WAS SEAL DAMAGE, AIR OR GAS LEAKAGE FROM THE SEAL AND ABNORMAL SOUND FROM THE DEVICE FOR THE FOUR DEVICES. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438445 ↗
• MalfunctionJan 3, 2024Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RECTAL RESECTION, WHILE ON RESECTION OF THE SURROUNDINGS OF RECTUM, THERE WAS SEAL DAMAGE, AIR OR GAS LEAKAGE FROM THE SEAL AND ABNORMAL SOUND FROM THE DEVICE FOR THE FOUR DEVICES. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436802 ↗
• MalfunctionDec 21, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, WHEN RESECTING AROUND THE RECTUM, THE 5 MM FORCEPS, THE SEAL OF THE DEVICE WAS DAMAGED, AND AIR OR GAS LEAKAGE FROM THE SEAL. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377653 ↗
• MalfunctionFeb 27, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOT-ASSISTED PROSTATECTOMY, ONE HOUR AFTER THE START OF THE PROCEDURE, THE SURGEON NOTICED THAT BLUE FOREIGN MATERIAL HAD FALLEN DURING LYMPH NODE DISSECTION AND COLLECTED IT. AFTER THAT, WHEN SEARCHING THE CAUSE, THE TROCAR VALVE WAS FOUND TO BE CHIPPED, AND THE FACT WAS REPORTED. IT WAS THAT THROUGH THE TROCAR, MAINLY INTESTINE GRASPING FORCEPS, 5MM AND 10MM RIGHT ANGLE FORCEPS AND NEEDLE HOLDER WITH NEEDLE HELD WERE INSERTED, AND IT WAS UNKNOWN WHICH ONE WAS BEING INSERTED THOUGH WHEN THE MATERIAL FELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767099 ↗
• MalfunctionMar 26, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, AN INSTRUMENT GOT CAUGHT AT THE SEAL OF THE TROCAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453965 ↗
• MalfunctionMar 18, 2019Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY SURGERY, THREE HOURS HAD PASSED AFTER THE OPERATION WAS STARTED, AN AIR LEAKAGE OCCURRED DUE TO SEAL BREAKAGE. IT WAS REPORTED THAT PNEUMOPERITONEUM COULD NOT BE KEPT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430312 ↗
• MalfunctionNov 19, 2018Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY, ABOUT 2 HOURS PASSED SINCE THE START OF SURGERY, AIR LEAK OCCURRED WITH THE SEAL STARTED SUDDENLY. BECAUSE THE SAME EVENTS OCCURRED CONTINUOUSLY IN THE LAST 3 CASES, THE DOCTOR ASKED WHETHER THE MATERIAL OF THE PRODUCT WAS CHANGED TO BE EASY TO BREAK. ALTHOUGH THE DEVICE WAS ABLE TO BE USED WITHOUT ANY PROBLEM, AIR LEAK OCCURRED WITH THE SEAL CONTINUOUSLY. WHEN THE COLLECTED PRODUCTS WERE CONFIRMED, A CUT PORTION OF ABOUT 2 MM IN THE UPPER SEAL WAS CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083932 ↗
• MalfunctionMay 5, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING A TRANSABDOMINAL PREPERITONEAL (TAPP) PROCEDURE. UPON OPENING THE PACKAGING, THE HEAD OF THE OBTURATOR DISENGAGED. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6547615 ↗