VersaOne B11STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10884521539853), received between Jan 17, 2017 and Jul 31, 2026 — classified as 1 death, 3 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 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 55 reports, in the reporter's own words as published by the FDA.

• DeathJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a laparoscopic procedure, pneumoperitoneum was created and the trocar was introduced when bleeding was observed. The blade of the trocar did not retract when went into cavity and hit and cut veins and arteries. The patient had tissue damaged and had blood loss of 500 cc or more. The patient had blood transfusion. The surgical time was  extended by 30 minutes or more. The patient died during surgery.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 50100991 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIORRHAPHY, WHILE AN ACCESS PORT WAS BEING USED FOR ACCESS VIA THE ABDOMINAL WALL, THE SEAL DISENGAGED, AIR OR GAS LEAKED FROM THE SEAL, AND THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO INJURY WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722740 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SEALING RUBBER INSIDE THE 11MM TROCAR CAME LOOSE, MAKING IT IMPOSSIBLE TO USE.

  Patient problems: Insufficient Information

  MAUDE report 23281094 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE RUBBER OF THE TROCAR CAME OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893716 ↗
• MalfunctionApr 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE MEMBRANE OF THE TROCAR RUPTURED DURING INTRODUCTION OF THE FORCEPS.

  Patient problems: Insufficient Information

  MAUDE report 21882281 ↗
• MalfunctionDec 30, 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 COLECTOMY, THE SEAL OF THE DEVICE BROKE AND FELL INTO THE PATIENT'S CAVITY. THE MATERIAL FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035532 ↗
• MalfunctionDec 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE TROCAR BROKE. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925400 ↗
• MalfunctionDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THERE WERE ISSUES WITH THE BLADED TROCAR. THE DEVICE EXPERIENCED A DISENGAGED SEAL AND A FAILURE OF THE LOCK, RESULTING IN THE BLUE RUBBER DETACHING FROM THE TROCAR. THE PROCEDURE WAS PERFORMED WITHOUT ANY INJURY TO THE PATIENT, AND NO ADDITIONAL OPERATION WAS REQUIRED TO CORRECT THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901923 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE CLIPPER WAS INTRODUCED, THE DOCTOR NOTICED THAT THE MEMBRANE HAD CAME LOOSE AND FALLEN INTO THE PATIENT'S CAVITY. THE DOCTOR REMOVED THE MEMBRANE FROM INSIDE THE PATIENT AND COMPLETED THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801038 ↗
• MalfunctionOct 29, 2024Break; Protective Measures Problem; Material Split, Cut or Torn; Break; Protective Measures Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC FUNDOPLICATION, THE SURGEON NOTICED THAT THE TROCAR HAD A RUPTURED MEMBRANE. IT WAS ALSO REPORTED THAT THE CANNULA BROKE. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559474 ↗
• MalfunctionOct 24, 2024Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC FUNDOPLICATION, AT THE START OF THE PROCEDURE, THE CANNULA BROKE. THERE WAS A RUPTURE OF THE TROCAR MEMBRANE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523090 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TROCAR VALVE CAME LOOSE WHEN IT CAUGHT ON THE TIP OF THE CLAMP. IT WAS NOTED THAT NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273695 ↗
• MalfunctionSep 19, 2024Decrease in Pressure; Material Split, Cut or Torn; Decrease in Pressure; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEAL HAD A DEFECT BREAKING THE DIAPHRAGM, CAUSING GAS LOSS. THERE WAS RAPID LOSS OF ABDOMINAL PRESSURE DUE TO THE DEVICE PROBLEM. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263005 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE PASSING THE FORCEPS AT THE BEGINNING OF THE PROCEDURE, THE MEMBRANE (SEAL) OF THE TROCAR 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 19561180 ↗
• MalfunctionMay 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE SEAL WAS DAMAGED. THE STAPLER COULD NOT BE FIRED. TO RESOLVE THE ISSUE, A NEW TROCAR, HANDLE AND RELOAD OF THE SAME TYPE WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356493 ↗
• MalfunctionMay 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE 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 19332717 ↗
• MalfunctionJan 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SEAL OF THE DEVICE DISENGAGED. THE SEAL FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED VIA FORCEPS. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581295 ↗
• MalfunctionJan 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE OBTURATOR BROKE AND THE TROCAR BLADE WAS NOT EXPOSED FOR USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18496937 ↗
• MalfunctionJan 4, 2024Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE TROCAR WAS INSERTED INTO THE ABDOMINAL WALL AFTER PNEUMOPERITONEUM, THE BLADE DID NOT RETRACT AFTER PERFORATING THE ABDOMINAL WALL TISSUE. THIS LED TO INJURIES IN THE ABDOMINAL WALL AND INTESTINAL LOOP. TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE, CAUTERIZATION AND SUTURING WERE PERFORMED. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Tissue Breakdown

  MAUDE report 18444154 ↗
• MalfunctionDec 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN BARIATRIC PROCEDURE, WHEN AT THE STOMACH, THE TROCAR HAD A LOOSE SEALING FILM, WHICH WAS DISENGAGED. IT WAS NOTED THAT NO COMPONENT FELL INTO THE CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387090 ↗
• MalfunctionDec 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE TROCAR BROKE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303777 ↗
• MalfunctionNov 17, 2023Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CHOLECYSTECTOMY, THE SEAL CAME LOOSE AND AIR/GAS LEAKED FROM THE DEVICE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160732 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SEAL DISENGAGED BUT DID NOT FALL INTO THE PATIENT'S CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949742 ↗
• MalfunctionAug 3, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE INSUFFLATION TO CREATE PNEUMOPERITONEUM, THE DEVICE LOST GAS. THE SEAL WAS NOT LEAKPROOF; IT WAS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 17454324 ↗
• MalfunctionAug 3, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE INSUFFLATION TO CREATE PNEUMOPERITONEUM, THE DEVICE LOST GAS. THE SEAL WAS NOT LEAKPROOF; IT WAS DAMAGED. ANOTHER TROCARS WERE TRIED BUT ALL WERE DAMAGED AND A METAL TROCAR WAS TAKEN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453387 ↗