VersaOne ONB11STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10884521657663), received between Oct 31, 2017 and May 28, 2026 — classified as 1 injury, 71 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (33 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 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Decrease in Pressure; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIORRHAPHY, THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT AND FELL INTO THE ABDOMINAL CAVITY, WHICH CAUSED A PROBLEM FOR ITS REMOVAL, SINCE IT HAD LOST THE MECHANISM TO PREVENT LEAKAGE OF INTRA-ABDOMINAL GAS. THERE WAS RAPID LOSS OF PNEUMOPERITONIUM. THE DEVICE WAS RETRIEVED USING SURGICAL INSTRUMENTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322749 ↗
• MalfunctionApr 7, 2026Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE FOR ENDOMETRIOSIS, AIR OR GAS LEAKED FROM THE SEAL AND THE SEAL WAS REPORTED AS DISENGAGED AND DAMAGED. REDUCER USE WAS REQUIRED TO STOP THE GAS LEAKAGE IN ORDER TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24803792 ↗
• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AT THE BEGINNING, THE TROCAR EXHIBITED A DISENGAGED SEAL. ALL PORTS WERE AFFECTED. THE ISSUE WAS RESOLVED BY CHANGING THE MATERIAL TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556099 ↗
• MalfunctionNov 13, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE SURGICAL TABLE FOR A LAPAROSCOPIC CHOLECYSTECTOMY, THE TROCAR WAS OBSERVED TO HAVE A LOOSE RUBBER SEAL AND THE SEAL WAS DAMAGED. THE ISSUES WERE IDENTIFIED WHEN THE SURGICAL ASSISTANT OPENED THE PACKAGING. THE DEVICE WAS REPLACED BY ANOTHER TROCAR TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543966 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE, A TEAR OF THE RUBBER SEAL LOCATED INSIDE THE TROCAR OCCURRED AND THE RUBBER SEAL BECAME DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 23281123 ↗
• MalfunctionJul 24, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE SURGERY, THE SEAL WAS DAMAGED AND LEAKAGE WAS NOTED. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 22585577 ↗
• MalfunctionOct 15, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC HYSTERECTOMY, AIR OR GAS LEAKED FROM THE SEAL. WHEN PASSING THE CLAMP, THE INTERNAL VALVE OF THE TROCAR BROKE CAUSING LEAKAGE OF THE PNEUMOPERITONEUM. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451700 ↗
• MalfunctionSep 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEAL FELL INTO THE CAVITY OF THE PATIENT AND WAS RECOVERED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212146 ↗
• MalfunctionSep 10, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN PASSING THE CLAMP, THE INTERNAL VALVE OF THE TROCAR BROKE CAUSING LEAKAGE OF PNEUMOPERITONEUM. THE MATERIAL WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183440 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIORRHAPHY, HALFWAY THROUGH THE PROCEDURE, THE UPPER MEMBRANE OF THE TROCAR INLET FELL INTO PATIENT CAVITY, AND WAS RETRIEVED BY THE SURGEON BY USING A TWEEZER. THE SURGEON USED A PERMANENT TROCAR TO FINISH THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944533 ↗
• MalfunctionJul 18, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE USING A CLIPPER, THE SEAL WAS DAMAGED AND DISENGAGED. THE RUBBER SEAL WAS RETRIEVED WITH TWEEZERS. A NEW TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770491 ↗
• MalfunctionJul 17, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHEN USING A CLIPPER THE SEAL OF THE DEVICE WAS DAMAGED AND IT FELL INTO THE PATIENT'S CAVITY. THE SEAL WAS ABLE TO BE RETRIEVED WITH TWEEZERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19762129 ↗
• MalfunctionJul 10, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SEAL DISENGAGED AND THERE WAS A GAS LEAK FROM THE SEAL. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712166 ↗
• MalfunctionJul 8, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC FUNDOPLICATION, WHILE IN THE STOMACH, THE SEAL OF THE TROCAR WAS TORN WHEN PASSING THE CLIPPER. THE TROCAR LEAKED. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19691186 ↗
• MalfunctionJul 5, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VIDEO CHOLECYSTECTOMY, THE SEAL WAS DAMAGED AND ENDED UP LOOSENING; THE DEVICE WAS IMPOSSIBLE TO USE. IT WAS ALSO REPORTED THAT THE GAS LEAKED. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680565 ↗
• MalfunctionJul 3, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING AN OPEN VIDEO PARTIAL NEPHRECTOMY, DURING PRE-SURGICAL PREPARATION, THE SEAL WAS DAMAGED AND THERE WAS A LEAKAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668056 ↗
• MalfunctionJul 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CANNULA BROKE. A NEW DEVICE WAS USED TO RESOLE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666158 ↗
• MalfunctionJul 1, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC CHOLECYSTECTOMY, DURING THE INSERTION OF THE TROCAR, THE BLUE VALVE WAS DAMAGED AND DETACHED FROM THE TROCAR, THEN FELL INTO THE PATIENT'S CAVITY. THE CANNULA ALSO DETACHED FROM THE TOP PORTION OF THE PORT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19647153 ↗
• MalfunctionJun 25, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC PROCTECTOMY, DURING LIGATION OF THE VESSEL, THE SEAL WAS DAMAGED AND THE BLUE WASHER FELL INTO THE PELVIC CAVITY BUT WAS REPORTED TO BE RETRIEVED WITH THE HELP OF GRASPERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611326 ↗
• MalfunctionJun 13, 2024Leak/Splash; Detachment of Device or Device Component; Human-Device Interface Problem; Leak/Splash; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE PERMANENT CLIP WAS INSERTED, THE SEAL VALVE FELL INTO THE CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE COMPONENT USING TWEEZERS. IT WAS ALSO NOTED THAT IT DID NOT TRANSFER GAS INTO THE PATIENT; THERE WAS A LEAK. ANOTHER COMPANY'S TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531407 ↗
• MalfunctionMay 16, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN PASSING THE SURGICAL FORCEPS, THE SEAL CAME LOOSE AND FELL INTO THE CAVITY OF THE PATIENT. THE SURGEON OPENED THE TROCAR HOLE FURTHER AND REMOVED THE SEAL WITH TWEEZERS. IT WAS ALSO NOTED THAT THE INCISION EXTENDED DUE TO THE PRODUCT PROBLEM. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19336868 ↗
• MalfunctionMay 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, THE INSTRUMENTS WERE USED, THE VALVE SEAL OF THE DEVICE WAS DAMAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310261 ↗
• MalfunctionMay 10, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, WHEN PASSING THE CLIP APPLIER, THE INTERNAL VALVE OF THE TROCAR RUPTURED, CAUSING LEAKAGE OF PNEUMOPERITONEUM. THE DEVICE WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288708 ↗
• MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE USER NEEDED TO USE A CLIP APPLIER, BUT THE BLUE RUBBER SEAL WAS TORN. ANOTHER 11-MM TROCAR WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288509 ↗
• MalfunctionMay 7, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN PASSING THE DEVICE ON THE TROCAR, THE SEAL OF THE TROCAR DISENGAGED AND THERE WAS A GAS LEAK. THE SEAL OF THE TROCAR FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITH A TWEEZERS. A PERMANENT TROCAR WAS USED INSTEAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264621 ↗