VersaOne NONB5SHFRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521546851), received between May 22, 2017 and May 5, 2025 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY, WHEN THE PORT WAS INSERTED, THE TIP OF THE OBTURATOR WAS PEELED OFF AND DROPPED, IT WAS ATTACHED TO THE ABDOMINAL CAVITY AND WAS REMOVED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961172 ↗
• MalfunctionOct 31, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC APPENDECTOMY, DURING TROCAR INTRODUCTION INTO THE ABDOMEN, THE PERITONEUM WAS OPENED WITH AN INTESTINAL BARREL CLAMP AROUND THE TROCAR FOR AN EASIER REACH INTRAPERITONEALLY, BUT THE SPIKE OF THIS TROCAR WAS RUBBED OFF BY AN INTESTINAL BARREL CLAMP AND TINY PLASTIC PIECES REMAINED AT THE TROCAR ENTRANCE ON THE ABDOMINAL WALL OF THE PATIENT. THE CANNULA BROKE. THE BITS OF PLASTIC HAD TO BE REMOVED FROM THE ABDOMINAL WALL LAPAROSCOPICALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15703298 ↗
• InjurySep 23, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROMONTOFIXATION, THERE WAS NO DIFFICULTY DURING THE PLACEMENT OF THE TROCARS, AT THE END OF THE VESICO-VAGINAL DISSECTION, AIR OR GAS LEAKED FROM THE SEAL ON THE 2 TROCARS. THE PATIENT DEVELOPED EMPHYSEMA IN THE UPPER THORAX AND FACE. THE USER STOPPED THE GAS AND INTERVENTION, CHECKED FOR ANESTHESIA AND BREATHING AND THERE WAS NO PROBLEM, THERE WAS NO BREACH MADE BY THE DOCTOR TO RESOLVE THE ISSUE. IT WAS NOTED THE SURGEON DID NOT SEE WHERE IT CAN COME FROM EXCEPT FOR THE TROCARS. IT WAS ALSO STATED THERE WAS ABSENCE OF SUBCUTANEOUS EMPHYSEMA AT THE ABDOMINAL LEVEL.

  Patient problems: Pulmonary Emphysema; Unspecified Tissue Injury

  MAUDE report 12519963 ↗
• InjuryNov 2, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE TROCAR WAS INTRODUCED, PLASTIC PARTICLES WERE DETACHED FROM IT AND ADHERED TO THE WALL (PERITONEUM) OF THE PATIENT. THE SAME TROCAR HAVING BEEN USED FOR THE PLACEMENT OF THE OTHER CANNULAS (3 SHORTS OF 5MM IN TOTAL), RESIDUES PLASTICS ARE ALSO OBSERVED AT THE INTRODUCTION SITES. IT WAS ALSO REPORTED THAT PERSISTENCE OF PLASTIC IN THE PATIENT WITH INABILITY TO REMOVE PLASTIC DEBRIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 10770862 ↗
• InjuryOct 31, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE INTRODUCING THE TROCAR, THERE WAS A PLASTIC RESIDUE LEFT IN THE PATIENT'S PERITONEUM. THERE WAS TISSUE DAMAGE AS A RESULT OF THE ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque; Tissue Damage

  MAUDE report 10767195 ↗
• InjuryAug 12, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL SALPINGECTOMY, THE CANNULA WAS BROKEN. THERE WAS A PRESENCE OF MICRO-FRAGMENTS OF THE CHUCK OF THE SUPRAPUBIC TROCAR IN THE WALL. PIECES THAT ARE VISIBLE WITHOUT HELP OF RADIOGRAPHY WERE REMOVED ONE BY ONE WITH PLIERS.

  Patient problems: Device Embedded In Tissue or Plaque; No Information

  MAUDE report 8882331 ↗
• MalfunctionNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, WHEN THE FORCEPS WERE TAKEN OUT OF THE TROCAR, THE BLUE SEAL PART INSIDE WAS REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083927 ↗
• MalfunctionOct 16, 2018Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER DURING A LAP. ASSISTED DISTAL GASTRECTOMY, IN THE MIDDLE OF THE PROCEDURE THE SEAL OF THE TROCAR BROKE. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7969120 ↗
• MalfunctionJun 26, 2018Difficult to Remove; Difficult to Open or Close; Mechanics Altered; Difficult to Remove; Difficult to Open or Close; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON WAS ABLE TO LOAD THE CLIP INSIDE THE PATIENT'S CAVITY, BUT WAS NOT ABLE TO CLIP IT. THE JAWS OF THE DEVICE WAS NOT ABLE TO CLOSE. THE HANDLE AND TROCAR WERE REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE WAS CAUSED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7637421 ↗
• MalfunctionApr 18, 2018Device Packaging Compromised; Sediment, Precipitate Or Deposit In Device Or Device Ingredient; Device Packaging Compromised; Sediment, Precipitate Or Deposit In Device Or Device Ingredient

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE DEVICE HAD A DAMAGED SEAL AND THERE WAS A WHITE RESIDUE ON THE HANDLE AND CLINICIANS REFUSED TO USE THEM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7440228 ↗
• MalfunctionSep 20, 2017Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, THE OBTURATOR BROKE BELOW THE HEAD OF THE DEVICE WHEN IT WAS INSERTED INTO ABDOMINAL WALL. THEY CHANGED THE DEVICE TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880158 ↗
• 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 6581442 ↗