VersaOne B12STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 180 adverse event reports that list this exact device (DI 10884521539877), received between Dec 6, 2016 and Sep 22, 2026 — classified as 2 deaths, 12 injuries, 166 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (78 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 180 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Protective Measures Problem

  It was reported that during a surgical procedure, the retractable blade mechanism failed to function as expected during insertion, resulting in gastric perforation.

  Patient problems: Perforation

  MAUDE report 50855076 ↗
• InjuryAug 6, 2026Detachment of Device or Device Component

  It was reported that during a laparoscopic cholecystectomy, when the physician went to access the abdominal cavity and when passing the clipper by the trocar, the top part of the trocar, the sealing membrane, came loose and fell into the cavity. The device was replaced to resolve the issue.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161030 ↗
• MalfunctionJun 16, 2026Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, THE VALVE OF THE TROCAR CANNULA RUPTURED, CAUSING A LEAK OF THE PNEUMOPERITONEUM. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25519106 ↗
• MalfunctionMay 28, 2026Difficult to Insert; Noise, Audible

  ACCORDING TO THE REPORTER INTRA-OPERATIVELY, THE SURGEON ATTEMPTED TO USE THE TROCAR BLADE WITHOUT SUCCESS AS THE PATIENT¿S SKIN WAS TOO THICK. THE TROCAR ALSO MADE A STRANGE NOISE. A NEW TROCAR WAS USED WHICH WAS ABLE TO GET INTO THE CAVITY.

  Patient problems: Insufficient Information

  MAUDE report 25312134 ↗
• MalfunctionMar 24, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED APPENDECTOMY, WHEN THE SURGEON WAS INTRODUCING THE STAPLER, THE SEAL DROPPED AT THE ABDOMINAL CAVITY. THE SURGEON RETRIEVED THE SEAL AND USED A NEW TROCAR TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681709 ↗
• MalfunctionMar 20, 2026Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF LAPAROSCOPIC APPENDECTOMY, DURING THE STAPLING PROCEDURE, UPON INSERTION OF THE LOAD ED STAPLER, THE RUBBER SEAL RUPTURED; IT WAS THEREFORE NECESSARY TO REPLACE THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647102 ↗
• MalfunctionMar 20, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF LAPAROSCOPIC COLECTOMY, AT THE MOMENT THE PHYSICIAN ATTEMPTED TO PERFORM THE STAPLING FOR THE SECOND TIME¿SPECIFICALLY, UPON INTRODUCING THE STAPLER WITH THE CARTRIDGE LOADED¿THE RUBBER SEAL RUPTURED AND FELL INTO THE ABDOMINAL CAVITY; IT WAS THEREFORE NECESSARY TO RETRIEVE THE SEAL AND REPLACE THE TROCAR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646733 ↗
• MalfunctionJan 12, 2026Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMICOLECTOMY, UPON INSERTION OF THE LINEAR STAPLER, THE SEAL WAS NOT FLEXIBLE AFTER HYDRATION, AND WHEN PRESSURE WAS APPLIED TO INSERT THE STAPLER, THE SEAL RUPTURED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039172 ↗
• MalfunctionNov 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE HAD A DAMAGED BLUE SEAL ON THE OUTSIDE, WHICH BROKE DURING USE. THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE CLIP DUE TO THE DEVICE ISSUE, AND WHEN ATTEMPTING TO REMOVE IT, THE SEAL BROKE. THE ISSUE WAS RESOLVED BY SUBSTITUTING THE DEVICE WITH ANOTHER ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583749 ↗
• MalfunctionNov 18, 2025Leak/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 LAPAROTOMY PROCEDURE, THERE WAS A RUPTURE OF THE BLUE SEAL MEMBRANE, WHICH RESULTED IN AN AIR LEAK. A RAPID LOSS OF CARBON DIOXIDE FROM THE PERITONEUM WAS NOTED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583690 ↗
• MalfunctionJul 9, 2025Break; Leak/Splash; Material Split, Cut or Torn; Break; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY WITH VIDEO VAGOTOMY, THE TROCAR BROKE WHILE A CLIP WAS BEING INSERTED, AND THE INTERNAL SILICONE TORE DURING THE PROCEDURE. AIR OR GAS LEAKED FROM THE SEAL, REQUIRING THE GAS IN THE CAVITY TO BE REPLACED. THE TROCAR WAS REPLACED TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462757 ↗
• MalfunctionApr 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE RUBBER OF THE DEVICE CAME OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882374 ↗
• MalfunctionJan 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, DEBRIS FROM A 12MM BLADED TROCAR GOT CAUGHT IN THE ABDOMINAL WALL DURING ENTRY, AND SOME DEBRIS FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE SURGEON, WHO TYPICALLY USED A HASSON TROCAR, HAD TO SPEND AN ADDITIONAL 30-45 MINUTES REMOVING ALL THE DEBRIS FROM THE PATIENT'S ABDOMINAL AREA. THE SURGICAL TIME WAS EXTENDED, BUT NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191747 ↗
• MalfunctionNov 22, 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, THE PLASTIC REGULATOR VALVE WAS LOOSE AND FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT. THE PIECE WAS REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757830 ↗
• MalfunctionNov 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, WHEN USING THE BLADED TROCAR, THERE WAS AN AIR LEAK DUE TO A DEFECT IN VALVE. WHILE USING THE POWERED STAPLER, THE RELOAD WAS NOT RECOGNIZED. THE PRODUCTS WERE REPLACED IN ORDER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611030 ↗
• MalfunctionNov 4, 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, INTRA-OPERATIVELY OF A GASTROPLASTY, THE SAFETY RUBBER CAME LOOSE INSIDE THE PATIENT. THE ISSUE WAS IMMEDIATELY IDENTIFIED. THE SEAL WAS ALSO DAMAGED. THE PIECE WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20601619 ↗
• MalfunctionOct 2, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ENDOMETRIOSIS AND RECTO SIGMOIDECTOMY, THE SEAL WAS DAMAGED AND THERE WAS A PROBLEM WITH THE FILM, CAUSING AIR LEAKAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351554 ↗
• MalfunctionSep 13, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED LAPAROSCOPIC GASTROPLASTY PROCEDURE, WHEN THE INSTRUMENT WAS INSERTED, THE TROCAR RUBBER SEAL BECAME LOOSE AND STARTED TO LEAK. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217931 ↗
• MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, ON THE APPENDIX, WHEN THE CLAMP WAS PASSED THROUGH THE TROCAR, THE TROCAR MEMBRANE WAS DAMAGED AND CAME LOOSE AND FELL INTO THE CAVITY OF THE PATIENT. PERMANENT CLAMPS WERE USED TO REMOVE THE MEMBRANE. THE ENTIRE MEMBRANE WAS REMOVED, AND NO PIECES REMAINED IN THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130246 ↗
• MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC, WHEN THE STAPLER PASSED THROUGH ONE TIME, THE TROCAR VALVE CAME LOOSE, AND FELL INTO PATIENT CAVITY. AFTER THE INCIDENT, THE SURGEON STOPPED THE PROCEDURE AND REMOVED EVERYTHING THAT HAD FALLEN INTO CAVITY BY USING A PERMANENT CLAMP. THE TROCAR WAS CHANGED INTO A NEW ONE AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086525 ↗
• MalfunctionJul 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, IN THE APPENDIX, THE TROCAR MEMBRANE CAME LOOSE AND FELL INTO THE PATIENT'S CAVITY, BUT NO PIECES REMAINED INSIDE THE PATIENT. THE PRODUCT WAS EXCHANGED FOR ANOTHER TO RESOLVE THE ISSUE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801241 ↗
• MalfunctionJul 15, 2024Leak/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 PARTIAL NEPHRECTOMY PROCEDURE, WHEN PASSING THE CLIP, THE INTERNAL VALVE OF THE TROCAR RUPTURED, CAUSING LEAKAGE OF THE PNEUMOPERITONEUM. IT WAS NOTED THAT THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE. TO RESOLVE THE ISSUE, AN EXCHANGE OF MATERIALS WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741187 ↗
• MalfunctionJul 11, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TROCAR WAS LEAKING. IT WAS NOTED THAT 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 19720128 ↗
• MalfunctionJul 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY PROCEDURE, AT THE BEGINNING, THE SEAL TORE, CAUSING THE LOSS OF PNEUMOPERITONEUM. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707203 ↗
• MalfunctionJul 2, 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, WHEN IN THE GALLBLADDER, THE SEAL OF THE TROCAR GOT DAMAGED. THE SEAL INSIDE WAS RELEASED IN THE HAND AFTER PASSING THE TWEEZERS. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656273 ↗