VersaOne BPT12STS (UDI 10884521515703)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884521515703), received between Apr 4, 2017 and Jul 15, 2025 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER PREOPERATIVELY, THE RING INSIDE THE BLUNT GRIP OF THE BLUNT PORT WAS BROKEN AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505804 ↗
• MalfunctionFeb 11, 2025Break; Break

  ACCORDING TO THE REPORTER DURING THE LAPAROSCOPIC APPENDECTOMY, THE TROCAR/OBTURATOR BROKE. FURTHERMORE, IT WAS UNCLEAR WHETHER THE SPRING LEVER WAS BROKEN OR JUST DISCONNECTED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353011 ↗
• MalfunctionJan 14, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN USING THE BLUNT PORT, IT WAS DAMAGED IMMEDIATELY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149654 ↗
• MalfunctionJul 26, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, INSERTION OF THE TROCAR, THE WHITE PLASTIC PIECE ABOVE THE ANCHOR 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 19844652 ↗
• MalfunctionDec 19, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING INSERTION OF THE TROCAR IN THE PATIENT, THE SUTURE WAS IN PLACE, THE WHITE PART WAS SQUEEZED TO PUT THE CANNULA AND IT BROKE. IT WAS NOTED THAT THE WHITE WINGS WHERE THE SUTURE WAS TIED 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 18357150 ↗
• MalfunctionAug 18, 2023Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE PINCH OF THE BLUNT GRIP WAS DAMAGED IMMEDIATELY AFTER OPENING AND ATTACHING IT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577465 ↗
• MalfunctionAug 16, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, AFTER INSERTING THE UMBILICAL PORT FOR CAMERA, WHEN ATTEMPTING TO FIXATE THE PRODUCT IN QUESTION IN THE ABDOMINAL WALL WITH A SUTURE. WHEN THE SUTURE WAS ATTACHED TO THE SUTURE SECURING PART OF THE BLUNT GRIP, THE WHITE PART BROKE INTO TWO PIECES. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560152 ↗
• MalfunctionJun 30, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN PACKAGE WAS OPENED, THE TROCAR WAS FOUND BROKEN AND THE SUTURE SECURING BAR WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240434 ↗
• MalfunctionDec 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ILEUS REMOVAL, WHEN OBSERVING THE ABDOMINAL CAVITY RIGHT BEFORE THE END OF THE SURGERY, A SMALL PIECE OF BLUE PLASTIC WAS FOUND IN THE CAVITY. THE PIECE WAS REMOVED USING FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16053053 ↗
• MalfunctionFeb 10, 2022Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE OBTURATOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508702 ↗
• MalfunctionJul 22, 2021Break; Break

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC CHOLECYSTECTOMY ONE OF THE SUTURE WINGS ABOVE THE THREADED ANCHOR BROKE DURING INSERTION. TO RESOLVE THE ISSUE, A NEW TROCAR WAS OPENED AND USED BY THE SURGEON TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214839 ↗
• MalfunctionMar 23, 2021Difficult to Insert; Packaging Problem; Difficult to Insert; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRECTOMY, WHEN INCISION IN THE UMBILICAL REGION WAS MADE AND TRIED TO INSERT AND FIX THE PORT, THE LEVER OF THE BLUNT GRIP WAS HARD (DID NOT MOVE AT ALL) AND SLEEVE WAS UNABLE TO BE FIXED. THE OBTURATOR BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558849 ↗
• MalfunctionJan 13, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, AFTER OPENING THE DEVICE PRE-OPERATIVELY, THEY FOUND THE HEAD PARTS OF THE OBTURATOR HAD COME OFF AND COULD NOT BE USED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11163751 ↗
• MalfunctionNov 3, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, WHILE SETTING UP PRE-OPERATIVELY, THE TROCAR WAS BROKEN WHERE THE SHAFT MEETS THE BLUE PART. THE SURGEON DISCARDED OFF SET UP AND REPLACED WITH ANOTHER DEVICE OF THE SAME CODE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10778581 ↗
• MalfunctionOct 24, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ABDOMINAL PROCEDURE, THE DEVICE TROCAR/OBTURATOR BROKE. IN ADDITION WHEN THE GAUZE WAS REMOVED FROM THE ABDOMINAL CAVITY, SOMETHING LIKE A PIECE OF PLASTIC WAS FOUND. THE PLASTIC PIECES WERE COLLECTED AND THE OPERATION WAS COMPLETED AS IT WAS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10731741 ↗
• MalfunctionSep 9, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TROCAR BROKE WHEN PLACING INTO PATIENT'S ABDOMEN. A SECOND TROCAR WAS PLACED INTO THE PATIENT'S ABDOMEN WITHOUT DIFFICULTY. THE TROCAR BROKE IN THE SAME PLACE THE FIRST ONE BROKE. ALL PARTS ACCOUNTED FOR AND PLACED IN BIOHAZARD BAG FOR REVIEW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511943 ↗
• MalfunctionAug 28, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, AFTER INSERTING INTO THE ABDOMEN, WHEN GRABBED THE LEVER IN ORDER TO ADJUST THE GRIP HEIGHT, THE DEVICE GOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10466401 ↗
• MalfunctionMay 7, 2020Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC CHOLECYSTECTOMY, THE FIXING PART OF THE TROCAR WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10031534 ↗
• MalfunctionApr 1, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE TROCAR GRIP BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911837 ↗
• MalfunctionApr 1, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, AFTER RETRIEVING THE GALL BLADDER DURING LAPAROSCOPIC CHOLECYSTECTOMY, AND WHEN THE PNEUMOPERITONEUM GAS WAS INJECTED AGAIN AND THE CAMERA WAS REINSERTED AND SET. THE BLUNT GRIP HAD BEEN BROKEN. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911805 ↗
• MalfunctionMar 4, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHILE INSERTING THE TROCAR INTO THE PATIENT, THE RING ON THE TROCAR BROKE IN HALF. ANOTHER TROCAR WAS OPENED AND AS IT WAS BEING ASSEMBLED, THE RING CRACKED IN TWO PLACES. A NEW TROCAR WAS OPENED BUT APPEARED TO CRACKED BUT HELD TOGETHER AND COMPLETED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787167 ↗
• MalfunctionFeb 27, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OOPHORECTOMY AND SALPINGECTOMY, THE KNOB OF THE DEVICE WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763460 ↗
• MalfunctionFeb 21, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC CHOLEDOCHOLITHOTOMY, WHEN THE BLUNT TIP OF THE DEVICE WAS SQUEEZED, IT BROKE INTO TWO PARTS. THE PRODUCT COULD NOT BE USED. THEY USED A NEW PRODUCT AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9739381 ↗
• MalfunctionFeb 5, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE OBTURATOR/TROCAR WAS BROKEN. ANOTHER TROCAR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9670711 ↗
• MalfunctionFeb 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PARTIAL COLECTOMY, A PLASTIC FRAGMENT OF ABOUT 5 X 2 MM WAS FOUND. THE PRODUCTS WERE DISASSEMBLED AND CHECKED AFTER THE PROCEDURE COMPLETED, BUT WHERE THE FRAGMENT FELL FROM COULD NOT BE IDENTIFIED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9659702 ↗