VersaOne UNVCA5SHFRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 30884521215416), received between May 22, 2017 and Apr 7, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Insufficient Device Problem Information; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PRIOR TO USE, THE OBTURATOR COULD NOT LOCK INTO THE CANNULA, IT AUTOMATICALLY PUSHED BACK SLIGHTLY. A DAMAGED SEAL WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800152 ↗
• MalfunctionAug 23, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SACRAL COLPOPEXY, WHEN INSERTING AND RETRACTING THE FORCEPS, THE SEAL BROKE DURING THE SURGERY AND AIR LEAKED OUT. THE DEVICE WAS REPLACED WITH ONE FROM ANOTHER LOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055418 ↗
• MalfunctionMay 22, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, ABOUT ONE HOUR AFTER THE OPERATION STARTED, THE SEAL BROKE AND THE AIR LEAK BECAME SEVERE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370869 ↗
• MalfunctionOct 19, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRECTOMY, WHEN A TROCAR WAS INSERTED INTO THE ABDOMINAL WALL, IT WAS OBSERVED THAT THE TIP OF THE SLEEVE (OUTER CYLINDER) WAS DAMAGED, AND IT WAS HANDLED BY TAKING OUT A NEW PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17971399 ↗
• MalfunctionOct 4, 2022Leak/Splash; Noise, Audible; Material Split, Cut or Torn; Leak/Splash; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL REPAIR, PNEUMOPERITONEUM GAS LEAKAGE OCCURRED. THE SEAL WAS DAMAGED AND HAD LEAKS. THE DEVICE MADE STRANGE NOISE. A NEW TROCAR WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540639 ↗
• MalfunctionJun 2, 2022Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHILE PREPARING, THE OBTURATOR/TROCAR BROKE. THERE SHOULD HAVE BEEN 6 INCLUDED IN 1 BOX, BUT ONLY 5 WERE PRESENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14574936 ↗
• InjuryNov 19, 2021Decrease in Pressure; Decrease in Pressure

  ACCORDING TO THE REPORTER, AT THE END OF A PROCEDURE, THERE WAS PNEUMOPERITONEUM LEAKAGE.

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

  MAUDE report 12844761 ↗
• MalfunctionFeb 16, 2021Difficult to Insert; Difficult to Remove; Packaging Problem; Difficult to Insert; Difficult to Remove; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRECTOMY, THE SEAL WAS DAMAGED. THERE WAS A RESISTANCE WHEN REMOVING AND INSERTING FORCEPS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333597 ↗
• MalfunctionJun 26, 2020Difficult to Insert; Packaging Problem; Difficult to Insert; Packaging Problem

  ACCORDING TO THE REPORTER, WHILE PREPARING DURING A LAPAROSCOPIC PROCEDURE, THE INNER SIDE OF THE CANNULA SHOWED SIGNS OF SCRATCHES AND WAS TOO NARROW AND TIGHT TO INTRODUCE THE INSTRUMENT SMOOTHLY OR WAS DAMAGED. THE DEVICE COULD ONLY GET INTO THE INNER WORKINGS BY PRESSING HARDER. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201538 ↗
• MalfunctionMar 18, 2020Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, AT THE TIME OF SETUP, THE OBTURATOR BECAME UNABLE TO BE REMOVED, SO THEY STOPPED USING THE DEVICE. BOTH DEVICE COLLECTED HAD THEIR OBTURATOR DIFFICULT TO BE REMOVED. 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 9847309 ↗
• MalfunctionJul 16, 2019Difficult to Remove; Noise, Audible; Difficult to Remove; Noise, Audible

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OVARIAN CYST REMOVAL PROCEDURE, WHILE ON INSTRUMENT REMOVAL, THE THREE INSTRUMENTS WERE TOO TIGHT IN THE PORTS AND THE DEVICES MADE A STRANGE NOISE. IT WAS SWAPPED FOR OTHER PORTS TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793242 ↗
• MalfunctionFeb 14, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, WHEN INSERTING FORCEPS AND HARMONIC DEVICES, THEY GOT CAUGHT. ANOTHER DEVICE WAS OPENED USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8339805 ↗
• MalfunctionDec 3, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE SURGEON FOUND THAT THE THREE TROCAR CANNULAS WERE BROKEN DURING INCISION. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8124314 ↗
• MalfunctionDec 3, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE SURGEON FOUND THAT THE THREE TROCAR CANNULAS WERE BROKEN DURING INCISION. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8124279 ↗
• MalfunctionMay 2, 2018Noise, Audible; Noise, Audible

  ACCORDING TO REPORTER, AFTER ONE HOUR OF USE IN A LAPAROSCOPIC COLECTOMY, STRANGE SOUND WAS HEARD. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT WAS REPORTER AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7480511 ↗
• MalfunctionNov 17, 2017Detachment Of Device Component; Device Packaging Compromised; Detachment Of Device Component; Device Packaging Compromised

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, THE TROCARS AND ULTRASOUND ABLATION DEVICE WERE USED. AFTER MULTIPLE PASSING OF THE ULTRASOUND DEVICE THROUGH THE TROCARS, THE SURGEON FOUND A BROKEN BLUE PIECE IN THE PATIENT'S ABDOMINAL CAVITY. IT WAS IMMEDIATELY RETRIEVED. SURGEON THINKS THAT THE BROKEN BLUE PIECE CAME FROM ONE OF THE TROCARS (SEAL PART) OR A GAUZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7042980 ↗
• MalfunctionMay 22, 2017Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC GYNECOLOGICAL PROCEDURE. WHEN INSERTING THE TROCAR INTO THE PATIENT, SCRATCHED THE TIP OF THE OBTURATOR CAUSING A LITTLE PIECE OF PLASTIC TO FALL INTO THE CAVITY OF THE PATIENT. THE PIECE WAS TAKEN OUT OF THE PATIENT AT THE END OF THE SURGERY THROUGH THE TROCAR. AN X-RAY WAS NOT PERFORMED TO LOCATE THE PLASTIC PIECE. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6581478 ↗

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-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-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-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-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-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-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