VersaOne NONB11STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884521546875), received between Mar 28, 2018 and May 12, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT AND ONE OF THE TROCAR MEMBRANES WAS OBSERVED TO BE DETERIORATING, WITH PIECES FALLING INTO THE TROCAR¿S INNER CAVITY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25154657 ↗
• MalfunctionMay 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, ONE OF THE MEMBRANES DETACHED FROM THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 25150032 ↗
• MalfunctionNov 11, 2025Decrease in Pressure; Detachment of Device or Device Component; Material Split, Cut or Torn; Decrease in Pressure; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE SURGEON INSERTED THE DEVICE FOR CLIP APPLICATION, THE SEAL OF THE TROCAR HAD DAMAGED AND FELL INTO THE PATIENT CAVITY. IT WAS MENTIONED ALSO THAT THERE WAS RAPID LOSS OF PNEUMOPERITONEUM MAKING IT IMPOSSIBLE TO CONTINUE THE SURGERY. THE TROCAR SEAL WAS THEN RETRIEVED FROM THE PATIENT CAVITY. THE SURGEON USED A NEW TROCAR FROM ANOTHER MANUFACTURER 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 23523509 ↗
• MalfunctionOct 16, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC HYSTERECTOMY, THE INSIDE OF THE TROCAR WAS SHREDDING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316997 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RUBBER OF THE TROCAR CAME OFF.

  Patient problems: Insufficient Information

  MAUDE report 21892756 ↗
• MalfunctionMar 26, 2025Leak/Splash; Detachment of Device or Device Component; Noise, Audible; Leak/Splash; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTROINTESTINAL STROMAL TUMOR (GIST ), THERE WAS A LEAK WHILE USING THE TROCAR, AND THE SEAL CAME OFF WHEN THE DEVICE WAS TAKEN OUT FROM THE TROCAR, ACCOMPANIED BY A STRANGE NOISE. TO RESOLVE THE ISSUE, ANOTHER COMPANY'S PRODUCT WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702322 ↗
• MalfunctionSep 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC CHOLECYSTECTOMY WITH CHOLANGIOGRAPHY, WHILE IN THE ABDOMINAL WALL, THE TROCAR PHYSICALLY BROKE. THE RUBBER OR SEAL OF THE TROCAR ALSO FELL INTO THE PATIENT'S ABDOMINAL CAVITY, REQUIRING ANOTHER TROCAR TO PERFORM THE SURGERY. THE FALLEN PIECED WERE RECOVERED USING GRASPING FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223265 ↗
• MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SEAL WAS LOOSE AND THEREFORE COULD NOT SEAL. THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359886 ↗
• MalfunctionMay 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEAL WAS DAMAGED DURING TROCAR INSERTION. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353735 ↗
• MalfunctionMay 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEAL WAS DAMAGED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332671 ↗
• MalfunctionDec 7, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE CANNULA BROKE DURING THE INSERTION OF THE TROCAR. AS A RESULT, COMPONENTS OF THE TROCAR FELL APART, LEAVING PIECES IN THE PATIENT'S ABDOMEN. FORTUNATELY, ALL THE TROCAR PIECES WERE SUCCESSFULLY RETRIEVED FROM THE ABDOMINAL CAVITY. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288634 ↗
• MalfunctionOct 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN PASSING THE CLIPPER, THE BLUE PART OF THE SEAL BROKE OFF INSIDE THE CANNULA. THERE WAS NO COMPONENT THAT FELL INTO THE PATIENT'S CAVITY. THE DEVICE WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856194 ↗
• MalfunctionSep 18, 2023Detachment 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 NEPHRECTOMY, WHEN INDUCING THE CLIPS, THE SEAL OF THE PORT WAS DAMAGED AND FELL INTO THE PATIENT¿S CAVITY. THE SEAL WAS RETRIEVED WITH A GRASPER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769485 ↗
• MalfunctionAug 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SEAL WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17615714 ↗
• MalfunctionApr 3, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VIDEO CHOLECYSTECTOMY, AT THE BEGINNING OF PROCEDURE, THE DIAPHRAGM OF THE DISPOSABLE TROCAR RUPTURED. ANOTHER TROCAR 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 16664405 ↗
• MalfunctionJul 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEAL OF THE DEVICE BROKE. THE SURGE ON DID NOT WANT ANOTHER TROCAR. SURGEON CONTINUED THE PROCEDURE WITH THE SAME TROCAR. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961476 ↗
• MalfunctionOct 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, THE SEAL BROKE DURING INITIAL INSERTION AND REMOVAL OF THE OBTURATOR. THE FRAYED SEAL WAS NOTICED IMMEDIATELY AND THE TROCAR WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720975 ↗
• MalfunctionMay 24, 2021Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING CHOLECYSTECTOMY PROCEDURE, 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 11871995 ↗
• MalfunctionMay 24, 2021Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING CHOLECYSTECTOMY, 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 11871879 ↗
• MalfunctionMay 24, 2021Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING BILATERAL INGUINAL HERNIA REPAIR, 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 11871860 ↗
• MalfunctionMay 24, 2021Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC 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 11871419 ↗
• MalfunctionOct 16, 2019Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THERE WAS AN AIR LEAK FROM THE SEAL. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE AS A RESULT OF THE PRODUCT PROBLEM. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198660 ↗
• MalfunctionFeb 24, 2019Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING THE TROCAR INSERTION AND DURING THE EXCHANGE OF THE HAND INSTRUMENTS IN A LAPAROSCOPIC CHOLECYSTECTOMY DURING PROCEDURE, THE SEAL OF THE DEVICE WAS DAMAGED, AND AIR OR GAS LEAKED FROM THE SEAL. THEY CHANGED THE DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8364697 ↗
• MalfunctionFeb 1, 2019Break; Packaging Problem; Break; Packaging Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE TROCAR HEAD WAS BROKEN. IT WAS EXCHANGED WITH ANOTHER TROCAR TO CONTINUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8297806 ↗
• MalfunctionJan 7, 2019Leak/Splash; Detachment of Device or Device Component; Packaging Problem; Leak/Splash; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE SEAL DISENGAGED AND WAS DAMAGED AND AN AIR OR GAS ALSO LEAKED FROM THE SEAL THE ENTIRE TIME. NEW TROCAR WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8224680 ↗