VersaOne B5STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10884521539839), received between Oct 25, 2016 and Sep 8, 2026 — classified as 10 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Detachment of Device or Device Component

  Patient problems: Foreign Body In Patient

  MAUDE report 50677503 ↗
• MalfunctionJul 22, 2025Leak/Splash; Decrease in Pressure; Material Split, Cut or Torn; Leak/Splash; Decrease in Pressure; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A TOTAL HYSTERECTOMY BY LAPAROSCOPY, A DEFECT IN THE VALVE SEAL IN ONE OF THE FIVE MILLIMETER TROCAR RESULTED IN THE ESCAPE OF AIR FROM THE PNEUMOPERITONEUM, WITH AIR OR GAS LEAKING FROM THE SEAL. THE AFFECTED TROCAR WAS REPLACED WITH ANOTHER ONE 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 22569533 ↗
• InjuryJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PEDIATRIC APPENDECTOMY, THERE WERE DEPOSITS OF PLASTIC DEBRIS IN THE PERITONEUM DURING THE INTRODUCTION OF A LAPAROSCOPIC SUPRAPUBIC TROCAR WITH ITS LOADED OBTURATOR WHERE THE PERITONEUM WAS LOOSER AND THEREFORE MORE DIFFICULT TO PENETRATE DUE TO FRICTION FROM A FENESTRATED LAPAROSCOPIC FORCEPS USED TO PASS THROUGH THE PERITONEUM (WITH COUNTER PRESSURE). THE SURGEON ATTEMPTED ABLATION WITHOUT SUCCESS. THE SURGEON WAS NOT ABLE TO REMOVE THE PLASTIC DEBRIS THAT FELL INTO THE PATIENT¿S CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22520042 ↗
• InjuryJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PEDIATRIC APPENDECTOMY, THERE WERE DEPOSITS OF PLASTIC DEBRIS IN THE PERITONEUM DURING THE INTRODUCTION OF A LAPAROSCOPIC SUPRAPUBIC TROCAR WITH ITS LOADED OBTURATOR WHERE THE PERITONEUM WAS LOOSER AND THEREFORE MORE DIFFICULT TO PENETRATE DUE TO FRICTION FROM A FENESTRATED LAPAROSCOPIC FORCEPS USED TO PASS THROUGH THE PERITONEUM (WITH COUNTER PRESSURE). THE SURGEON ATTEMPTED ABLATION WITHOUT SUCCESS. THE SURGEON WAS NOT ABLE TO REMOVE THE PLASTIC DEBRIS THAT FELL INTO THE PATIENT¿S CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22519997 ↗
• InjuryJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PEDIATRIC APPENDECTOMY, THERE WERE DEPOSITS OF PLASTIC DEBRIS IN THE PERITONEUM DURING THE INTRODUCTION OF A LAPAROSCOPIC SUPRAPUBIC TROCAR WITH ITS LOADED OBTURATOR WHERE THE PERITONEUM IS LOOSER AND THEREFORE MORE DIFFICULT TO PENETRATE DUE TO FRICTION FROM A FENESTRATED LAPAROSCOPIC FORCEPS USED TO PASS THROUGH THE PERITONEUM (WITH COUNTER PRESSURE). THE SURGEON ATTEMPTED ABLATION WITHOUT SUCCESS. THE SURGEON WAS NOT ABLE TO REMOVE THE PLASTIC DEBRIS THAT FELL INTO THE PATIENT¿S CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22487287 ↗
• InjuryJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PEDIATRIC APPENDECTOMY, THERE WERE DEPOSITS OF PLASTIC DEBRIS IN THE PERITONEUM DURING THE INTRODUCTION OF A LAPAROSCOPIC SUPRAPUBIC TROCAR WITH ITS LOADED OBTURATOR WHERE THE PERITONEUM IS LOOSER AND THEREFORE MORE DIFFICULT TO PENETRATE DUE TO FRICTION FROM A FENESTRATED LAPAROSCOPIC FORCEPS USED TO PASS THROUGH THE PERITONEUM (WITH COUNTER PRESSURE). THE SURGEON ATTEMPTED ABLATION WITHOUT SUCCESS. THE SURGEON WAS NOT ABLE TO REMOVE THE PLASTIC DEBRIS THAT FELL INTO THE PATIENT¿S CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22471071 ↗
• InjuryJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE CANNULA BROKE WHEN THE SURGEON INSERTED THE TROCAR, RESULTING IN A BLUE PARTICLE FROM THE DEVICE FALLING INTO THE PATIENT CAVITY. THE SURGEON RETRIEVED ALL OF THE BLUE PART FROM INSIDE THE PATIENT ONE BY ONE. THERE WAS UNANTICIPATED TISSUE LOSS AND LED TO AN EXTENSION OF THE PATIENT'S HOSPITALIZATION.

  Patient problems: Tissue Breakdown

  MAUDE report 22201808 ↗
• MalfunctionMay 14, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, WHEN OPENING THE PACKAGING, THE TROCAR WAS BROKEN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021776 ↗
• MalfunctionDec 13, 2024Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, THE BLADE OF THE TROCAR DID NOT ACTIVATE WHEN THE DOCTOR ATTEMPTED TO PLACE IT, AND THE KNIFE WAS DIFFICULT TO ADVANCE. THE TROCAR WAS CHANGED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20927448 ↗
• MalfunctionNov 14, 2024Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AT THE BEGINNING OF THE PROCEDURE, THE TROCAR DOES NOT PIERCE SINCE THE BLADE DOES NOT COME OUT. ANOTHER DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684667 ↗
• MalfunctionOct 29, 2024Break; Noise, Audible; Break; Noise, Audible

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ESOPHAGECTOMY IVOR LEWIS, WHILE INSERTING THE OBTURATOR INTO THE PATIENT, A CRACK WAS HEARD AND THE OBTURATOR WAS SPLIT IN HALF. THE SURGEON WAS USING MULTIPLE TROCARS, SO THE SURGEON USED ANOTHER OBTURATOR TO PLACE THE TROCAR AND DID NOT HAVE THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558442 ↗
• MalfunctionJun 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TROCAR WAS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 19516132 ↗
• MalfunctionJun 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE PIECES FROM THE TIP OF THE TROCAR FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED MANUALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468433 ↗
• MalfunctionApr 19, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PARTIAL COLECTOMY, AFTER 30 MINUTES OF USE OF THE DEVICE, THE DOCTOR OBSERVED THAT GAS WAS LEAKING AND FOUND THAT THE TROCAR SEAL WAS TORN. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19146807 ↗
• MalfunctionMar 7, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF A LAPAROSCOPIC PROCEDURE, WHEN THE TROCARS WERE REMOVED, THE SURGEON FOUND SMALL BLUE PLASTIC FRAGMENTS FROM THE TROCAR STYLET AT THE LEVEL OF THE SUPRAPUBIC TROCAR INCISION OR HOLE. THE TROCAR BROKE.

  Patient problems: Insufficient Information

  MAUDE report 18860103 ↗
• MalfunctionFeb 21, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, WHILE PLACING THE TROCAR ON THE ABDOMEN TO MAKE A HOLE FOR THE LIVER RETRACTOR, THE OBTURATOR BROKE. THE SURGEON PULLED THE DEVICE OUT TO RESOLVE THE ISSUE. WHEN THE JAWS OF THE DEVICE WERE CLOSED, THE SURGEON FELT THAT THE RELOAD NEVER LOOKED FULLY CLOSED WHEN IT WAS STATED THE DEVICE WAS FULLY SHUT. NONETHELESS, THE DEVICE WAS STILL ABLE TO FIRE. IT WAS NOTED THAT NO ISSUE WITH THE HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754569 ↗
• MalfunctionFeb 7, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC FUNDOPLICATION, THE LENS OF THE DEVICE DISENGAGED AND THE DEVICE WAS LEAKING. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18662868 ↗
• MalfunctionFeb 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE TROCAR SEAL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18662109 ↗
• MalfunctionFeb 7, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TUMOR REMOVAL, THE TROCAR WAS UNPLUGGED. WHEN THE SURGEON WAS TRYING TO INSERT THE TROCAR TO THE CANNULA, IT WAS REPORTED THAT IT DID NOT FIT CORRECTLY THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661896 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE THE SURGEON WAS PUTTING THE TROCAR IN AND WHEN REMOVING THE OBTURATOR FROM THE SLEEVE, THE OBTURATOR BROKE IN HALF. THE USER JUST REMOVED THE OBTURATOR AND PUT BACK THE SLEEVE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460124 ↗
• MalfunctionDec 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INTERSPHERICAL , RESECTION, TOTAL MESORECTAL EXCISION AND COLORECTAL ANASTOMOSIS, AFTER USING THE CLIP APPLIER THE MEMBRANE (SEAL) WAS BROKEN. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18368023 ↗
• MalfunctionDec 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN A LAPAROSCOPIC CLAMP IS INSERTED, THE MEMBRANE OF THE DEVICE RUPTURED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347399 ↗
• MalfunctionDec 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY, WHEN INSERTING A CLAMP, THE MEMBRANE RUPTURE. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250789 ↗
• InjuryOct 5, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, WHEN THE 5MM TROCAR WAS INTRODUCED INTO THE INTRAPERITONEAL CAVITY, THE SHAFT DISINTEGRATED, COMPONENT DISENGAGED INTO THE CAVITY, SMALL BLUE SHAVINGS INSIDE THE CAVITY. IT WAS NOTED THAT THE PIECES WAS RETRIEVED AND X-RAY USED. THE DEVICE WAS CHANGE TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 17878125 ↗
• MalfunctionJun 23, 2023Break; Mechanical Problem; Break; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTROINTESTINAL PROCEDURE, WHEN INSERTING THE TROCAR INTO THE PATIENT AT THE BEG INNING OF PROCEDURE, THE BLADE WAS ENABLED AND TROCAR WAS INTRODUCED TO THE PATIENT. WHEN USING DEVICE FOR THE SECOND TIME, THE BLADE DID NOT ENGAGE AND 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 17191028 ↗