VersaOne RNONB8STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10884521717640), received between Nov 24, 2020 and Aug 24, 2026 — classified as 7 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (29 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421577 ↗
• MalfunctionJul 2, 2025Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE OBTURATOR DID NOT GET INTO THE TROCAR.

  Patient problems: Insufficient Information

  MAUDE report 22386220 ↗
• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC LEFT PARTIAL NEPHRECTOMY PROCEDURE, A SMALL PART OF THE CANNULA BROKE OFF. NO COMPONENT FALL INTO THE CAVITY OF THE PATIENT. THE ISSUE WAS RESOLVED BY CHANGING TO ANOTHER TROCAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312297 ↗
• InjuryJun 19, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY AND LYMPHADENECTOMY PROCEDURE, WHILE PLACING THE TROCARS IN THE PATIENT WHILE THEY WERE ALREADY UNDER ANESTHESIA BUT PRIOR TO THE START OF THE OPERATION, IT WAS FOUND THAT THE ENTIRE TROCAR SHAFT WAS WITHIN THE ABDOMINAL WALL, THE TIP WAS BARELY PROTRUDING FROM THE CAVITY, AND THE UPPER PART OF THE TROCAR HAD LOW MOBILITY AND WAS IN CONTACT WITH THE SKIN. WHEN THE PATIENT WAS PLACED IN THE TRENDELENBURG POSITION, THE PATIENT COULD NOT SUPPORT THE POSITION FOR LONG. THERE WEREN'T ANY LONG TROCARS, SO THE SURGERY WAS CANCELLED BECAUSE THEY COULD NOT AFFORD COMPLICATIONS WITH THIS PATIENT. THE SURGERY WILL BE PERFORMED LAPAROSCOPICALLY AT A LATER DATE WITHOUT ROBOTIC SUPPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22293450 ↗
• InjuryJun 19, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY AND LYMPHADENECTOMY PROCEDURE, WHILE PLACING THE TROCARS IN THE PATIENT WHILE THEY WERE ALREADY UNDER ANESTHESIA BUT PRIOR TO THE START OF THE OPERATION, IT WAS FOUND THAT THE ENTIRE TROCAR SHAFT WAS WITHIN THE ABDOMINAL WALL, THE TIP WAS BARELY PROTRUDING FROM THE CAVITY, AND THE UPPER PART OF THE TROCAR HAD LOW MOBILITY AND WAS IN CONTACT WITH THE SKIN. WHEN THE PATIENT WAS PLACED IN THE TRENDELENBURG POSITION, THE PATIENT COULD NOT SUPPORT THE POSITION FOR LONG. THERE WEREN'T ANY LONG TROCARS, SO THE SURGERY WAS CANCELLED BECAUSE THEY COULD NOT AFFORD COMPLICATIONS WITH THIS PATIENT. THE SURGERY WILL BE PERFORMED LAPAROSCOPICALLY AT A LATER DATE WITHOUT ROBOTIC SUPPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22293416 ↗
• InjuryJun 19, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY AND LYMPHADENECTOMY PROCEDURE, WHILE PLACING THE TROCARS IN THE PATIENT WHILE THEY WERE ALREADY UNDER ANESTHESIA BUT PRIOR TO THE START OF THE OPERATION, IT WAS FOUND THAT THE ENTIRE TROCAR SHAFT WAS WITHIN THE ABDOMINAL WALL, THE TIP WAS BARELY PROTRUDING FROM THE CAVITY, AND THE UPPER PART OF THE TROCAR HAD LOW MOBILITY AND WAS IN CONTACT WITH THE SKIN. WHEN THE PATIENT WAS PLACED IN THE TRENDELENBURG POSITION, THE PATIENT COULD NOT SUPPORT THE POSITION FOR LONG. THERE WEREN'T ANY LONG TROCARS, SO THE SURGERY WAS CANCELLED BECAUSE THEY COULD NOT AFFORD COMPLICATIONS WITH THIS PATIENT. THE SURGERY WILL BE PERFORMED LAPAROSCOPICALLY AT A LATER DATE WITHOUT ROBOTIC SUPPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22293275 ↗
• InjuryJun 19, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY AND LYMPHADENECTOMY PROCEDURE, WHILE PLACING THE TROCARS IN THE PATIENT WHILE THEY WERE ALREADY UNDER ANESTHESIA BUT PRIOR TO THE START OF THE OPERATION, IT WAS FOUND THAT THE ENTIRE TROCAR SHAFT WAS WITHIN THE ABDOMINAL WALL, THE TIP WAS BARELY PROTRUDING FROM THE CAVITY, AND THE UPPER PART OF THE TROCAR HAD LOW MOBILITY AND WAS IN CONTACT WITH THE SKIN. WHEN THE PATIENT WAS PLACED IN THE TRENDELENBURG POSITION, THE PATIENT COULD NOT SUPPORT THE POSITION FOR LONG. THERE WEREN'T ANY LONG TROCARS, SO THE SURGERY WAS CANCELLED BECAUSE THEY COULD NOT AFFORD COMPLICATIONS WITH THIS PATIENT. THE SURGERY WILL BE PERFORMED LAPAROSCOPICALLY AT A LATER DATE WITHOUT ROBOTIC SUPPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22289736 ↗
• MalfunctionJun 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, PATIENTS EXPERIENCED ABDOMINAL PAIN AT THE TROCAR INCISIONS AND ABDOMINAL TENSION AT THE TROCAR SITES. TO ADDRESS THE ISSUE, THE SURGICAL TEAM CAREFULLY DOCKED THE ARMS AND RELEASED THE TENSION IN DIFFERENT POSITIONS OF THE ARMS.

  Patient problems: Abdominal Pain; Pain

  MAUDE report 22186510 ↗
• MalfunctionJun 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE USING A TROCAR, THE PATIENT EXPERIENCED TEMPORARY ABDOMINAL PAIN AT THE TROCAR INCISIONS. THE PAIN WAS ATTRIBUTED TO ABDOMINAL TENSION DUE TO NOT USING LONG BARIATRIC TROCARS. THE PROCEDURE WAS A ROBOTIC LAPAROSCOPIC SURGERY, AND THE TENSION WAS PRESENT THROUGHOUT THE SURGERY BETWEEN THE TROCARS AND THE SKIN. TO ADDRESS THE ISSUE, THE ARMS WERE CAREFULLY DOCKED, AND TENSION WAS RELEASED IN DIFFERENT POSITIONS.

  Patient problems: Abdominal Pain; Pain

  MAUDE report 22184230 ↗
• MalfunctionMay 7, 2025Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE OBTURATOR COULD NOT BE PUT INSIDE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976516 ↗
• MalfunctionMay 5, 2025Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 8MM TITANIUM TROCAR FROM THE ROBOTIC-ASSISTED SURGERY SYSTEM CANNOT BE PUT INSIDE THE 8MM OBTURATOR OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21959977 ↗
• MalfunctionFeb 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, WHILE PREPARING THE TABLE AT THE BEGINNING OF THE SURGERY, BEFORE TROCAR PLACEMENT, IT WAS NOTED THAT THE 8MM OBTURATOR WAS NOT COMPATIBLE WITH THE 8MM TITAN TROCAR. ANOTHER OBTURATOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461326 ↗
• MalfunctionOct 21, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN ATTEMPTING TO INSERT THE INTERNAL CYLINDER UNIT TO THE CANNULA, THE INTERNAL CYLINDER UNIT BECAME STUCK AND COULD NOT MOVE AFTER PASSING THROUGH THE SEAL. BOTH INSERTION AND REMOVAL WERE IMPOSSIBLE. THERE WAS ALSO AN ABNORMAL SOUND COMING FROM THE DEVICE. A MEDICAL PROFESSIONAL WHO PREPARED THE DEVICE APPLIED SIGNIFICANT FORCE TO REMOVE IT FROM THE CANNULA. ANOTHER INTERNAL CYLINDER UNIT WAS BROUGHT IN AND INSERTED INTO THE CANNULA, THE INTERNAL CYLINDER UNIT PASSED THROUGH WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494969 ↗
• MalfunctionOct 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THERE WERE SEVERAL ISSUES THAT OCCURRED DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY. FIRST, DURING THE VESICLES DISSECTION STEP, THERE WAS A BIPOLAR MARYLAND FORCEPS INSTRUMENT ERROR. THE BMF WAS REMOVED AND REPLACED WITH A NEW ONE. SECOND, DURING THE PROSTATE DISSECTION STEP, THE TROCAR BROKE AND THE PLASTIC SHEET PIECE FELL INTO THE PATIENT BUT WAS RETRIEVED. THERE WAS A 5 MINUTE DELAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462352 ↗
• MalfunctionJul 8, 2024Difficult to Insert; Vibration; Difficult to Insert; Vibration

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC BYPASS, THE PATIENT HAS A PENICLE LARGER THAN EXPECTED, WHICH FORCED THE ENTIRE STEM OF THE TROCAR TO BE INSERTED INSIDE THE PATIENT TO REACH THE INTRA-ABDOMINAL CAVITY. THE TROCAR EXERTED A LOT OF FORCE AND CONSEQUENTLY THE ARMS VIBRATE WHEN MOVING. A ROBOTIC BARIATRIC TROCAR (150MM) WAS REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19692536 ↗
• MalfunctionJun 12, 2024Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC SLEEVE PROCEDURE, WHEN THE SURGEON PERFORMED BARIATRIC SURGERY ON AN OBESE PATIENT, IT WAS NECESSARY TO USE LONGER TROCARS. SINCE THE STANDARD TROCAR HAD TO BE INTRODUCED ENTIRELY TO REACH THE ABDOMINAL CAVITY, IT BECAME IMPOSSIBLE TO MOVE OR ADJUST THE TWO TROCARS WITHOUT EXERTING SIGNIFICANT FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524362 ↗
• InjuryMay 23, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A LAPAROSCOPIC BYPASS WAS GOING TO BE PERFORMED WITH THE ROBOT. AT THE TIME OF PLACING THE ROBOTIC TROCARS, THE SURGEON REALIZED THAT THE TROCARS HAD TO BE FULLY INSERTED TO REACH THE ABDOMINAL CAVITY, WHICH MEANT THAT THE TROCAR HAD NO MOBILITY. THE TROCAR WAS NOT LONG ENOUGH. FOR THIS REASON, THE SURGEON DECIDED TO CONVERT THE SURGERY TO LAPAROSCOPY. IN THE END, THE SURGERY HAS NOT BEEN CONVERTED LAPAROSCOPY EITHER BECAUSE THE PATIENT DECOMPENSATED, THUS SUSPENDING THE SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19385878 ↗
• MalfunctionMar 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, WHEN MOBILIZING THE PROSTATE, THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT, AND WHITE PIECES OF THE TOP HUB BROKE OFF WITH THE BOTTOM PART. THE TROCAR WAS REMOVED AND REPLACED WITH ANOTHER ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896581 ↗
• InjuryFeb 29, 2024Difficult to Insert; Product Quality Problem; Difficult to Insert; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROSTHETIC DEVICE EXTRACTION, THE STANDARD TROCAR APPEARED TO BE TOO SHORT FOR THE PATIENT. SWITCHING INSTRUMENTS WAS VERY DIFFICULT, AND THE LOSS OF POSITIONING OF THE TROCARS THROUGH THE WALL WAS RECURRENT AND RISKY. THIS IS DUE TO THE FACT THAT THE PATIENT HAD A HIGH BODY MASS INDEX (BMI), A PNEUMOPERITONEUM, AND TRENDELENBURG LIMITATIONS. THE PATIENT ALSO HAD A VERY THICK ABDOMINAL WALL WITH A LOT OF FAT LAYERS INSIDE THE ABDOMINAL WALL. THE SURGEON CONVERTED TO OPEN SURGERY FOR PATIENT SAFETY AND DUE TO THE DELAY GENERATED BY THE LIMITATIONS OF THE TROCARS, IN WHICH THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. AN INCISION OF MORE THAN 1 INCH WAS MADE IN THE PUBIC AREA TO ACCESS THE TARGET ANATOMY. THE PATIENT HAD 5 MORE DAYS POST-OP SURGERY AND HAD AN INFECTION RESULTING FROM THE LAPAROTOMY. MOREOVER, THE PATIENT EXTENDED HOSPITALIZATION FOR 7 DAYS MORE, AND AN ADDITIONAL OPERATION WILL BE PERFORMED TO CORRECT THE ISSUE.

  Patient problems: Laceration(s); Unspecified Infection

  MAUDE report 18809031 ↗
• MalfunctionJan 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, WHILE INSERTING THE MESH, THE RUBBER PART DETACHED AND ADHERED TO THE MESH, FALLING INTO THE ABDOMINAL CAVITY. IT WAS IMMEDIATELY RETRIEVED WITH LAPAROSCOPIC FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441445 ↗
• MalfunctionDec 22, 2023Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RIGHT HEMICOLECTOMY WITH ROBOT SUPPORT PROCEDURE, WHEN TISSUE DEPLOYMENT WAS BEING CHANGED FOR PASSIVE TREATMENT OF A PART OF HEPATOMA, A CRASHING SOUND WAS HEARD. UPON CHECKING THE JOINT BETWEEN THE SEAL AND THE TROCAR, IT WAS VISUALLY CONFIRMED THAT THE LEVER AT THE CONNECTION OF THE DEVICE HAD BEEN 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 18387208 ↗
• MalfunctionMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC AND ROBOTIC PARTIAL NEPHRECTOMY, WHEN RETRACTING TISSUE WITH THE FORCEPS, THERE WAS A SCRATCHES ON PATIENT SKIN DUE TO THE POSITION OF THE 3 WAY COCK. THE TROCAR WAS PLACED CORRECTLY (FULCRUM BAND), THE SURGEON BURPED THE PORT BUT STILL THERE WAS A TENSION ON THE PATIENT SKIN FOR SOME ARM CART ASSEMBLY (ACA) POSITIONS. THE STOPCOCK DID NOT BROKE BUT IT CONCERNS THE STOPCOCK.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16916841 ↗
• MalfunctionFeb 8, 2023Entrapment of Device; Entrapment of Device

  ACCORDING TO THE CLINICAL STUDY, 6 DAYS POST-OPERATIVE OF A RADICAL PROSTATECTOMY, THE PATIENT HAD NAUSEA, VOMITING, ABDOMINAL PAIN, HEMATURIA, NO STOOLS, AND SCANTY FLATUS. ABDOMINAL COMPUTED TOMOGRAPHY (CT) SCAN SHOWED ILEUS OF THE SMALL INTESTINE. DIAGNOSTIC LAPAROSCOPY WHICH WAS DONE DUE TO THE COMPUTED TOMOGRAPHY (CT) SCAN, ALSO SHOWED ILEUS. THE PATIENT WAS TREATED WITH SURGERY AS INTERVENTION FOR THE ILEUS. THE PATIENT WAS FURTHER GIVEN INTRAVENOUS ANTIBIOTICS DUE TO HIGH INFECTION RATES CAUSED BY THE ILEUS. THE ADVERSE EVENTS ARE CAUSALLY RELATED TO THE STUDY PROCEDURE AND ARE NOT RELATED TO THE DEVICES. CONCURRENTLY, WITH THE COMPUTED TOMOGRAPHY (CT) SCAN AND REOPERATION, THE BOWEL WAS CONFIRMED TO HAVE BEEN STUCK TO THE SURGICAL PORT.

  Patient problems: Insufficient Information

  MAUDE report 16330442 ↗
• InjuryOct 21, 2022Difficult to Insert; Connection Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED DURING ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE, DURING THE PROSTATE DISSECTION. THE TROCAR SLIPPED OUT FROM THE PATIENT'S FASCIA DURING BLADDER FLAP (PATIENT WEIGHT 126 KG, 1M83). THE TROCAR NEEDED TO BE REINSERTED. THE MCS WERE REMOVED AND TROCAR REINSERTED. WHILE REINSERTING, THE ASSISTANT FELT RESISTANCE AND THE LIGHT EMITTING DIODES (LEDS) BECAME SOLID WHITE. THERE WAS AN INSTRUMENT CALIBRATION ISSUE. THE MONOPOLAR CURVED SHEARS (MCS) WERE DETACHED, JAWS CLOSED, REATTACHED AND INSERTED BUT IT DID NOT CALIBRATE. THE POSITION OF THE TROCAR WAS CHANGED AND MCS REINSERTED BUT THE PROBLEM PERSISTED. THE MCS WERE CHANGED FOR A NEW PAIR AND THE ISSUE WAS RESOLVED. THERE WAS A YELLOW ALARM THAT CAME UP RANDOMLY: "ERROR IN CONTROL HANDLES. CENTER AND STRAIGHTEN EQUIPMENT AT WORKSPACE AND REMOVE HANDS. IF THE ERROR PERSISTS, STOP USING THE SURGEON CONSOLE." THE ALARM WAS IGNORED AND DISAPPEARED AFTER A COUPLE OF MINUTES. SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. ANESTHESIA WAS EXTENDED DUE TO THE TROCARS NOT BEING LONG ENOUGH AND KEPT SLIPPING OUT OF THE PATIENT CAVITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15649930 ↗
• MalfunctionMar 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, FOLLOWING LAB EVALUATION, IT WAS NOTED THAT THE PROXIMAL SEAL OF THE PORT HAD A VERY SMALL TEAR IN IT. THERE WAS NO DAMAGE OBSERVED AT THE BEGINNING OF THE EVALUATION WHEN THE PACKAGING OF THE PORT WAS FIRST OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693742 ↗