VersaOne B11STSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521539860), received between Nov 16, 2018 and May 13, 2026 — classified as 3 injuries, 2 malfunctions.

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

• InjuryMay 13, 2026Break; Detachment of Device or Device Component; Protective Measures Problem

  IT WAS REPORTED THAT DURING THE FIRST STEP OF A LAPAROSCOPIC COLORECTAL SURGERY USING AN ACCESS PORT, THE KNIFE AND ITS COVER OPENED DURING USE AND THE KNIFE WAS DIFFICULT TO ADVANCE. THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT, AND THE STOPCOCK BROKE. IT WAS ALSO NOTED THAT THE INCISION WAS EXTENDED DUE TO THE PRODUCT PROBLEM BY MORE THAN 1 INCH. THE PROCEDURE WAS COMPLETED BY OPENING AND USING ANOTHER TROCAR FROM A DIFFERENT MANUFACTURER.

  Patient problems: Laceration(s)

  MAUDE report 25157417 ↗
• MalfunctionMar 24, 2023Leak/Splash; Decrease in Pressure; Material Split, Cut or Torn; Leak/Splash; Decrease in Pressure; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON PUT IN THE 5 MILLIMETER GRASPER, THE SEAL HAD DAMAGED AND BEGAN TO LEAK AND THE PATIENT BEGAN TO LOSE INSUFFLATION. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611511 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING INSERTION OF THE TROCAR, REOPERATION WAS NEEDED. THE PATIENT WAS HOSPITALIZED. THERE WAS AN UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE. THE INCISION WAS EXTENDED. THERE WAS BLEEDING FROM THE ABDOMINAL WALL ON THE EPIGASTRIC ARTERY. THERE WAS PATIENT INJURY.

  Patient problems: Blood Loss; Injury; No Code Available; Tissue Damage

  MAUDE report 8404093 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THERE WAS BLEEDING FROM THE ABDOMINAL WALL FROM THE EPIGASTRIC ARTERY DURING INTRODUCTION OF THE TROCAR. THE SURGERY WAS CONVERTED TO AN OPEN SURGERY TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 8403319 ↗
• MalfunctionNov 16, 2018Gas/Air Leak; Packaging Problem; Gas/Air Leak; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SEAL WAS DAMAGED AND WHEN A 5MM INSTRUMENT IS INSERTED INTO THE 11MM PORT, THE SEAL WAS NOT ADJUSTING AND CO2 GAS WOULD LEAK AND PNEUMOPERITONEUM WAS BEING LOST. A 5MM TROCAR WAS USED TO REPLACE THE 11MM. THE SURGERY WAS EXTENDED BY 30 MINUTES, BUT THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8077329 ↗