VersaOne BPT12STS (UDI 20884521621050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 20884521621050), received between Dec 21, 2017 and Aug 18, 2026 — classified as 5 injuries, 154 malfunctions.

The most frequently reported specific device problem is “Break” (92 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 159 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299888 ↗
• InjuryMay 29, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE INNER END OF THE CANNULA BROKE INSIDE THE ABDOMEN. THE SURGERY WAS CONVERTED TO AN OPEN PROCEDURE, AND AN X-RAY WAS PERFORMED BUT THE BROKEN CANNULA WAS NOT DETECTED. ON (B)(6) 2026, THE PATIENT HAD A COMPUTED TOMOGRAPHY SCAN, BUT THERE WAS NO FRAGMENT FOUND. THE SURGICAL TIME WAS EXTENDED BY TWO HOURS TO FIND THE FRAGMENT AND HOSPITALIZATION WAS EXTENDED BY THREE MORE DAYS IN ORDER TO DETERMINE THE POSSIBLE VISUALIZATION OF THE TROCAR FRAGMENT IN THE ABDOMEN, ALTHOUGH THE PATIENT APPEARED TO BE IN GOOD CONDITION.

  Patient problems: Laceration(s); Unintended Radiation Exposure

  MAUDE report 25332741 ↗
• MalfunctionMar 5, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LIVER CYST REMOVAL PROCEDURE, A SMALL ONE CENTIMETER PIECE OF PLASTIC WAS FOUND IN THE ABDOMEN AND WAS SUSPECTED TO HAVE COME FROM THE INNER RING OF THE CAP OF THE DEVICE. THE COMPONENT WAS RETRIEVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521652 ↗
• MalfunctionDec 17, 2025Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING CLINICAL, DURING UTEROLYSIS WITH EXCISION OF ENDOMETRIOSIS WHEN THE PORT WAS PLACED ON THE 11MM ADAPTER, IT RESULTED IN A RAPID LOSS OF PNEUMOPERITONEUM AND INABILITY TO MAINTAIN THE IT. THE SURGEON TRIED MULTIPLE TECHNIQUES FOR TROUBLE SHOOTING INCLUDING CHANGING INSUFFLATION EQUIPMENT TO AIR SEAL (WHICH PROVIDES MORE RAPID REPLACEMENT OF PNEUMOPERITONEUM TO MATCH LOSSES), WRAPPING THE TROCAR WITH GAUZE TO IMPROVE THE FIT BETWEEN ADAPTER DESIGNED FOR 12 MM STANDARD TROCAR AND THE 11 MM ROBOTIC TROCAR BUT IT MOVED THROUGH THE GAS QUICKLY. THE 11MM TROCAR BEING INCOMPATIBLE WITHOUT ADJUSTMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831996 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE PERIOPERATIVE NURSE WAS PREPARING THE INSTRUMENTS, THE OBTURATOR/TROCAR BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741374 ↗
• MalfunctionNov 25, 2025Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PRODUCT WAS OPENED, THE PARTS WERE CRACKED OR BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642494 ↗
• MalfunctionSep 15, 2025Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED THAT PREOPERATIVELY, THE OBTURATOR/TROCAR WAS FOUND BROKEN WHEN THE STAFF OPENED THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23054080 ↗
• MalfunctionSep 8, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROCEDURE, DURING TROCAR INSERTION, WHEN THE DEVICE WAS OPENED, THE THREADED ANCHOR WAS ALREADY DISPLACED. THE CLAMP THAT HOLDS THE ANCHOR IN PLACE WAS DAMAGED. THE STOPCOCK OF THE TROCAR BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22989949 ↗
• MalfunctionJul 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, WHEN THE NURSE TRIED TO INSERT THE INNER TUBE INTO THE OUTER TUBE TO USE AS A CAMERA PORT IN THE NAVEL AFTER OPENING THE PACKAGE, IT WAS NOTICED THAT THE HEAD OF THE INNER TUBE HAD CRACKED AND SEPARATED. A NEW PRODUCT WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609600 ↗
• MalfunctionJun 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, THE PORT EXHIBITED A CRACK IN THE WHITE KNOB WHILE BEING PREPARED FOR USE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324800 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE HEAD PART OF THE OBTURATOR (INNER TUBE) WAS DETACHED UPON OPENING. IT WAS HANDLED BY TAKING OUT A NEW PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22189452 ↗
• MalfunctionMay 16, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE PRODUCT WAS TAKEN OUT OF THE PACKAGE, THE HEAD OF THE OBTURATOR WAS DISCONNECTED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039996 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE TOP OF THE TROCAR BROKE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968584 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT THE OBTURATOR/TROCAR BROKE PRIOR TO USE. WHEN THE STORE MANAGER OPENED THE BOX AND FOUND THE OBTURATOR IS BROKEN IN THE PACK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21869655 ↗
• MalfunctionMar 13, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC PROCEDURE, WHEN THE PORT WAS INSERTED THROUGH A SMALL INCISION AND WAS ABOUT TO BE FIXATED, THE GRIP BROKE. ADDITIONALLY, THE OBTURATOR OR TROCAR RUPTURED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596462 ↗
• MalfunctionJan 22, 2025Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER PRIOR TO USE, THE CANNULA WAS CHIPPED OR HAD PIECES OF OTHER FOREIGN MATTER INSIDE IT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208687 ↗
• MalfunctionJan 15, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL LIVER RESECTION: THE PRODUCT WAS INSERTED AND THE NEEDLE AND SUTURE WERE AN CHORED/FIXATED. DURING SURGERY, WHILE ATTEMPTING TO ADJUST THE POSITION BY SQUEEZING THE KNOB ON THE GRIP PART OF THE PRODUCT, THE GRIP PART BROKE OR WAS DAMAGED. THE CANNULA FELL OFF FROM THE UPPERMOST PART OF THE PORT. ANOTHER TROCAR FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159621 ↗
• MalfunctionJan 15, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159559 ↗
• InjuryNov 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY, WHILE USING THE PORT IN THE CHEST, THE PORT TURNED, AND THE END SHATTERED. SOME PIECES WERE REMOVED THORACOSCOPICALLY, AND A MINI THORACOTOMY WAS PERFORMED TO CONFIRM THAT ALL PIECES HAD BEEN REMOVED.

  Patient problems: Laceration(s)

  MAUDE report 20798259 ↗
• MalfunctionNov 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), WHEN INSERTING THE FIRST CAMERA PORT, THE CANNULA RUPTURED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20647148 ↗
• MalfunctionNov 6, 2024Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, WHILE IN THE MIDDLE OF THE OPERATION, THERE WAS AN AIR LEAK FROM THE TROCAR AND ABDOMINAL WALL. WHEN THE CLIP ON THE BLUE GRIP PART WAS CLAMPED AND THE GRIP WAS TWISTED AND INSERTED INTO THE ABDOMINAL WALL, THE CLIP PART GOT DETACHED BUT DID NOT FALL INTO THE ABDOMINAL CAVITY SINCE IT WAS FIXATED ON THE ABDOMINAL WALL WITH ABSORBABLE SUTURES. TO RESOLVE THE ISSUE, A NEW DEVICE FROM ANOTHER MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623671 ↗
• MalfunctionOct 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE OBTURATOR/TROCAR RUPTURED. THE SPRING LEVER DETACHED AND BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20521072 ↗
• MalfunctionJun 3, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HERNIA REPAIR, THE ANCHOR TAB OF THE 12MM. TROCAR BROKE OFF. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445183 ↗
• MalfunctionMay 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HEAD PART OF OBTURATOR AND THE TUBE PART BROKE EVEN THOUGH THERE WAS NOT MUCH LOAD APPLIED TO THE DEVICE. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356465 ↗
• MalfunctionMay 16, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, AFTER THE DEVICE WAS TAKEN OUT OF THE PACKAGE THE OBTURATOR'S HEAD WAS FOUND TO BE DISLODGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336710 ↗