VersaOne RUNVCA8STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521717664), received between Feb 21, 2023 and Mar 6, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY WITH ROBOT SUPPORT FOR ASCENDING COLON CANCER, THE MONOPOLAR WAS REMOVED ONCE FOR THE CLIP, WHEN REINSERTING IT AFTERWARD THE MONOPOLAR WOULD NOT ADVANCE. THE TIP OF THE FORCEPS WAS CAUGHT ON THE MESH VALVE SEAL INSIDE THE PORT. AFTERWARD, BLUE FIBERS WERE ATTACHED TO THE TIP OF THE MONOPOLAR THAT HAD ENTERED THE BODY, AND WAS RETRIEVED BY ATTACHING IT TO GAUZE. CARE WAS TAKEN TO PREVENT THE FORCEPS FROM GETTING CAUGHT, AND THE PROCEDURE WAS CONTINUED AS IS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537477 ↗
• MalfunctionFeb 26, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL COLECTOMY USING THE HUGO ROBOT, THE STANDARD ROBOTIC TROCARS DID NOT PASS THROUGH THE INNER WALL OF THE ABDOMINAL WALL, WHICH WAS NOT ANTICIPATED PRIOR TO THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED BY 1.5 HOURS DUE TO THE INABILITY TO USE THE STANDARD ROBOTIC TROCARS, RESULTING IN A DELAY IN SURGERY. THE INCISION WAS EXTENDED, BUT NOT MORE THAN 1 INCH. THE PROCEDURE WAS CONVERTED FROM ROBOTIC TO LAPAROSCOPIC, AND THE STANDARD ROBOTIC TROCARS WERE REPLACED WITH LONG LAPAROSCOPIC TROCARS FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455735 ↗
• MalfunctionDec 13, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE EVENT OCCURRED DURING A ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY PROCEDURE, WHEN THE PATIENT WAS IN THE OPERATING ROOM AND UNDER ANESTHESIA. SHORTLY AFTER DOCKING, WHEN TRYING TO INSERT THE MONOPOLAR CURVED SHEARS ONTO ARM 4, IT WAS BLOCKED INSIDE OF THE TROCAR. THE MONOPOLAR CURVED SHEARS WAS DETACHED AND REATTACHED, BUT IT DID NOT CHANGE ANYTHING. LOOKED AS IF THERE WAS SOMETHING BLUE INSIDE OF THE TROCAR. THE SHEARS WERE WITHDRAWN AND THE TROCAR WAS TAKEN OUT OF THE PATIENT. TRIED TO FREE THE CANNULA FROM THE BLUE PART IT HAD INSIDE BUT WITH NO SUCCESS. A NEW SINGLE USE TROCAR WAS USED TO CONTINUE WITH THE PROCEDURE. THE SEAL OF THE TROCAR SEEMED TO BE INTACT. LATER, THE BIPOLAR MARYLAND FORCEPS WERE NOT RECOGNIZED. THE STERILE INTERFACE MODULE (SIM) WAS DETACHED FROM THE ARM WHILE MAKING SURE THE STERILITY WAS PRESERVED, AND THEN REATTACHED. THE BIPOLAR MARYLAND FORCEPS WERE THEN RECOGNIZED. THEN AN INSTRUMENT ERROR OCCURRED DURING THE PREPARATION OF THE PROSTATE AT ONE HOUR AND TWENTY-FIVE MINUTES. THE BIPOLAR MARYLAND FORCEPS WERE REMOVED FROM THE PATIENT, DETACHED FROM THE SIM, REATTACHED AND REINSERTED. AT ONE HOUR AND THIRTY MINUTES THERE WAS ANO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20927452 ↗
• InjuryNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOT ASSISTED COLON RESECTION, BEFORE ATTEMPTING ANASTOMOSIS, THE SEAL WAS DAMAGED , DISLODGES AND FALLS INTO THE PATIENT¿S CAVITY. AN X-RAY WAS PERFORMED TO LOCATE AND A LAPAROSCOPIC FORCEPS WAS USED TO RETRIEVE ALL THE FALLEN PARTS. THERE WAS NO PNEUMOPERITONEUM LEAKAGE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20745326 ↗
• MalfunctionFeb 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY WITH ROBOT SUPPORT, THE SEAL DISENGAGED. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18724134 ↗
• MalfunctionMar 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC RADICAL PROSTATECTOMY, AT THE BEGINNING OF ANASTOMOSIS (LIGATION OF DORSAL VENOUS COMPLEX), PORT WAS USED MOSTLY FOR THE MONOPOLAR CURVED SHEARS (MCS). THE LAST TIME THE MCS WAS EXCHANGED, PART OF THE BLUE PORT SEAL WAS FOUND ATTACHED TO THE INSTRUMENT TIP AS IT WENT INSIDE THE PATIENT. TO CONTINUE THE CASE, THE PORT PART WAS REMOVED FROM THE INSTRUMENT. PROCEDURE WAS DELAYED BY FIVE MINUTES AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16498596 ↗
• MalfunctionFeb 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY MID-PROCEDURE, WHEN THE PORT WAS REMOVED THE BLUE SEAL OF THE TROCAR WAS DAMAGED. NOTHING WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408350 ↗