VersaOne NONB12LGFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521546912), received between May 16, 2017 and Sep 27, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Break; Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC BARIATRIC SLEEVE GASTRECTOMY, THREE TROCARS FROM TWO BARIATRIC KITS HAD ISSUES. THE SEALS WERE DAMAGED, AIR OR GAS LEAKED FROM THE SEALS, AND THE STOPCOCKS BROKE. THE SEALS OF THE TROCARS BROKE OFF AFTER THE INSERTION OF CAMERA AND OTHER INSTRUMENTS. THE SEALS FELL INTO THE PATIENT CAVITY. DUE TO THIS EVENT, THE PNEUMOPERITONEUM WAS LOST, THE TROCARS HAD TO BE REPLACED, AND THE SEAL IN THE PATIENT'S CAVITY HAD TO BE LOOKED FOR AND REMOVED. THE SURGICAL TIME WAS DELAYED FOR 5 MINUTES DUE TO CHANGING TROCARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826367 ↗
• MalfunctionMay 24, 2021Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING FUNDOPLICATION, WHEN THE SURGEON INSERTED THE LAPAROSCOPIC INSTRUMENTS, THE MEMBRANE BROKE AND LEAKED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871859 ↗
• MalfunctionMay 24, 2021Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A RIGHT INGUINAL HERNIA PROCEDURE, WHEN THE SURGEON INSERTED THE LAPAROSCOPIC INSTRUMENTS, THE TWO TROCARS' MEMBRANES BROKE AND LEAKED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869626 ↗
• MalfunctionMay 24, 2021Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING AN APPENDECTOMY, WHEN THE SURGEON INSERTED THE LAPAROSCOPIC INSTRUMENTS, THE MEMBRANE BROKE AND LEAKED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869597 ↗
• MalfunctionDec 2, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN ENTERING THE ABDOMEN, THE OBTURATOR/TROCAR BROKE. NOTHING WAS USED TO COMPLETE THE CASE AS THE ACCOUNT NOTICED THAT THE TIP OF THE TROCAR HAS SERRATION ON IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9394666 ↗
• MalfunctionAug 26, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING MANIPULATION OF THE TISSUE ON A ROBOTIC LAPAROSCOPIC MYOMECTOMY, THE CANNULA BROKE. ANOTHER DEVICE WAS OPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8933362 ↗
• MalfunctionMay 16, 2017Detachment Of Device Component; Leak/Splash; Device Packaging Compromised; Detachment Of Device Component; Leak/Splash; Device Packaging Compromised

  ACCORDING TO THE REPORTER, DURING A APPENDECTOMY, THERE WAS A DAMAGED SEAL AND THERE WAS AIR OR GAS LEAKING FROM THE SEAL. THE INNER MEMBRANE OF THE ACCESS PORT BROKE OFF AND FELL INTO THE ABDOMEN OF THE PATIENT DURING THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THE MEMBRANE WAS REMOVED AND THE ABDOMINAL CAVITY WAS CLEANED WITH NORMAL SALINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6570487 ↗