VersaOne NONB12STSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521546899), received between Oct 8, 2019 and Sep 23, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

• InjurySep 23, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROMONTOFIXATION, THERE WAS NO DIFFICULTY DURING THE PLACEMENT OF THE TROCARS, AT THE END OF THE VESICO-VAGINAL DISSECTION, AIR OR GAS LEAKED FROM THE SEAL ON THE 2 TROCARS. THE PATIENT DEVELOPED EMPHYSEMA IN THE UPPER THORAX AND FACE. THE USER STOPPED THE GAS AND INTERVENTION, CHECKED FOR ANESTHESIA AND BREATHING AND THERE WAS NO PROBLEM, THERE WAS NO BREACH MADE BY THE DOCTOR TO RESOLVE THE ISSUE. IT WAS NOTED THE SURGEON DID NOT SEE WHERE IT CAN COME FROM EXCEPT FOR THE TROCARS. IT WAS ALSO STATED THERE WAS ABSENCE OF SUBCUTANEOUS EMPHYSEMA AT THE ABDOMINAL LEVEL.

  Patient problems: Pulmonary Emphysema; Unspecified Tissue Injury

  MAUDE report 12519881 ↗
• MalfunctionOct 8, 2019Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SURGEON BROKE THE INNER SEAL OF THE TROCAR WHILE INSERTING A LARGE REUSABLE CLIP APPLIER. A SECOND TROCAR WAS PROVIDED BUT THE SAME ISSUE OCCURRED. BOTH SEALS WERE RETRIEVED FROM THE PATIENT'S ABDOMEN USING A GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9168365 ↗