VersaOne ONB5SHFRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10884521657625), received between Jun 26, 2017 and Jun 9, 2025 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

6 other recalls cover devices cleared under the same FDA submission (K112349); they may or may not involve this specific model.

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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Break; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion; Break; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, A BLUE FOREIGN OBJECT WAS IDENTIFIED INSIDE THE PACKAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172927 ↗
• MalfunctionJan 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, WHEN ATTEMPTING TO REINSERT AND REMOVE THE 5 MILLIMETER SCOPE WITH THE OPTICAL METHOD INSERTED, THE HOUSING SECTION ALSO CAME 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 21159323 ↗
• MalfunctionSep 17, 2024Leak/Splash; Decrease in Pressure; Noise, Audible; Leak/Splash; Decrease in Pressure; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, APPROXIMATELY FIVE HOURS AFTER THE START OF THE SURGERY, AN AIR LEAK OCCURRED WITH A SOUND DUE TO THE PNEUMOPERITONEUM COULD NOT BE MAINTAINED. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE DUE TO THE DEVICE ISSUE. THE TWO LEAKING TROCARS WERE REPLACED WITH NEW ONES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239685 ↗
• MalfunctionMay 10, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY RESECTION PROCEDURE, THE PART BELOW THE OBTURATOR BUTTON WERE 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 19293535 ↗
• MalfunctionFeb 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790005 ↗
• MalfunctionJan 16, 2024Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE INNER TUBE (OBTURATOR) WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519336 ↗
• MalfunctionJan 16, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA TRANSABDOMINAL PRE-PERITONEAL (TAPP), WHEN PUNCTURING THE PORT, THE CANNULA WAS CHIPPED OR BROKEN. A NEW PORT DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518483 ↗
• MalfunctionDec 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA SURGERY, THE TROCAR SEAL CAME OFF. THERE WAS NO COMPONENT THAT FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275873 ↗
• MalfunctionOct 20, 2023Break; Melted; Break; Melted

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ILEOCECAL RESECTION, WHEN THE TROCAR WAS PUNCTURED AND ADHESIOLYSIS WAS BEING PERFORMED, AFTER A FEW MINUTES OF USE, IT WAS FOUND THAT THE TIP OF THE OUTER TUBE HAD BEEN DAMAGED AND HAD TRACES OF WHAT APPEARED TO BE MELTING. A NEW PRODUCT WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980971 ↗
• MalfunctionJul 6, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, THERE WAS AN AIR LEAKAGE, AND WHEN THE TROCAR WAS CHECKED, THE SEAL WAS DAMAGED. THE PRODUCT WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17267398 ↗
• MalfunctionMay 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROCEDURE, DURING INSTRUMENT INSERTION, THE SEAL OF THREE TROCARS DISENGAGED. NEW TROCARS WERE OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974206 ↗
• MalfunctionMay 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROCEDURE, DURING INSTRUMENT INSERTION, THE SEAL OF THREE TROCARS DISENGAGED. NEW TROCARS WERE OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974195 ↗
• MalfunctionMay 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROCEDURE, DURING INSTRUMENT INSERTION, THE SEAL OF THREE TROCARS DISENGAGED. NEW TROCARS WERE OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974185 ↗
• MalfunctionMay 10, 2023Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, PREOPERATIVELY, IN THE FRONT ROOM, WHEN ASSEMBLING THE RELEVANT NEW PRODUCT, WHICH IS THE INNER TUBE/OUTER TUBE SETTING. THE INNER TUBE WAS STUCK AND WAS DIFFICULT TO ATTACH. WHEN THE JAGGED RIBS OF THE OUTER TUBE WERE CHECKED CLOSED, THE CAUSE WAS THAT THERE WAS DAMAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903608 ↗
• MalfunctionMar 18, 2023Break; Difficult to Insert; Break; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, WHEN INSERTING THE TROCAR, THE INNER CYLINDER COULD NOT BE REMOVED AFTER THE TROCAR RUPTURED. A NEW TROCAR 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 16570021 ↗
• MalfunctionMar 17, 2023Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOIDECTOMY, AIR LEAKS COULD BE SEEN EVERY TIME THE FORCEPS WERE PUT IN AND TAKEN OUT OF THE RELEVANT TROCAR. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE DUE TO THE DEVICE ISSUE. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564708 ↗
• MalfunctionDec 6, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING PREOPERATIVE PREPARATION, THE INNER CYLINDER DID NOT DETACH FROM THE OUTER CYLINDER. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THE DEVICE WAS NOT USED ON PATIENT. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926016 ↗
• MalfunctionOct 26, 2022Break; Difficult to Remove; Break; Difficult to Remove

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC INTESTINAL OR JEJUNAL ILEUS PROCEDURE, WHEN THE SECOND TROCAR WAS INSERTED INTO THE ABDOMINAL WALL IN ORDER TO START THE OPERATION. THE INNER TUBE COULD NOT BE REMOVED DESPITE REPEATED ATTEMPTS. THE OBTURATOR OR TROCAR RUPTURED. THE OUTER TUBE WAS ALSO REMOVED, THEN A NEW TROCAR WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677880 ↗
• MalfunctionOct 24, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RIGHT RESECTION, WHENEVER INSERTING AND RETRACTING THE FORCEPS FROM THE TROCAR TO GRASP THE COLON OR THE LIGAMENT, LITTLE BY LITTLE AIR LEAKED OUT FROM SEAL, SO THE PNEUMOPERITONEUM COULD NOT BE MAINTAINED. IT WAS ALSO NOTED THAT THE SEAL WAS DAMAGED. THE SAME EVENT OCCURRED ON ANOTHER TROCAR WITH A DIFFERENT LOT NUMBER. TWO ADDITIONAL TROCARS WERE USED AND THE TWO NEW ONES DID NOT LEAK AIR AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659153 ↗
• MalfunctionOct 24, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RIGHT RESECTION, WHENEVER INSERTING AND RETRACTING THE FORCEPS FROM THE TROCAR TO GRASP THE COLON OR THE LIGAMENT, LITTLE BY LITTLE AIR LEAKED OUT FROM SEAL, SO THE PNEUMOPERITONEUM COULD NOT BE MAINTAINED. IT WAS ALSO NOTED THAT THE SEAL WAS DAMAGED. THE SAME EVENT OCCURRED ON ANOTHER TROCAR WITH A DIFFERENT LOT NUMBER. TWO ADDITIONAL TROCARS WERE USED AND THE TWO NEW ONES DID NOT LEAK AIR AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659099 ↗
• MalfunctionAug 30, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AROUND TWO HOURS AFTER THE START OF THE SURGERY, ON TWO DEVICES, WHEN THE FORCEPS WERE INSERTED, THE PNEUMOPERITONEUM LEAKED. WHEN THE FORCEPS ARE REMOVED, THE PNEUMOPERITONEUM WAS MAINTAINED. IT WAS ALSO NOTED THAT THE SEAL WAS DAMAGED. TO RESOLVE THE ISSUE, A DIFFERENT PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322392 ↗
• MalfunctionJul 26, 2022Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE INSERTING THE TROCAR, THE OBTURATOR COULD NOT BE REMOVED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103809 ↗
• MalfunctionMar 21, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SEAL CRACKED AND AIR LEAKED FROM THE DEVICE WHEN THE FORCEPS WERE INSERTED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841142 ↗
• MalfunctionFeb 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ILEOCECAL RESECTION PROCEDURE, DURING THE INITIAL PREPARATION STAGE, AN ATTEMPT WAS MADE TO PULL OUT THE OBTURATOR OF THE TROCAR, BUT IT COULD NOT BE PULLED OUT EVEN WHEN THE WHITE PORCH WAS SUPPRESSED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13455419 ↗
• MalfunctionJan 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SURGERY FOR UTERINE MALIGNANCY, AT FORCEPS INSERTION, THE SEAL WAS DAMAGED. A NEW PORT 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 13225272 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112349. One submission often covers many models, so check the product and lot details in each record.

• Z-1468-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynec
• Z-1472-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general,
• Z-1471-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, ge
• Z-1467-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gyneco
• Z-1469-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic,
• Z-1470-2013 · May 6, 2013 · Terminated
  Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gyne