VersaOne NONB15LGFRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521548107), received between Jul 3, 2017 and Nov 17, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (20 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE TROCAR WAS VERY TIGHT, MAKING IT DIFFICULT TO INSERT A BLACK 60 MM STAPLER RELOAD DOWN THE TROCAR, AND THE SEAL ON THE PORT WAS FOUND TO BE DAMAGED. THE SURGEON WAS ALSO USING SEAM GUARD ON THE RELOAD DURING THE INSERTION OF THE STAPLER. THE PROCEDURE WAS COMPLETED USING A COMPETITIVE TROCAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569186 ↗
• MalfunctionJan 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SEAL DISENGAGED. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287973 ↗
• MalfunctionJun 23, 2023Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE USING THE 10 MILLIMETER TROCAR TO THE BACK OR FRONT, THE BLUE SEAL ON THE PORT WAS TORE OFF ALL AROUND, AND IT CAME OFF WHILE STILL ATTACHED TO THE SCOPE. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195523 ↗
• MalfunctionMay 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE BLUE INNER SEAL CAME OFF. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17003712 ↗
• MalfunctionDec 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC LOWER SLEEVE RESECTION, WHEN REMOVING THE RELOAD FROM THE 15 MM PORT, WHEN THE STOMACH WAS RESECTED, THE PORT SEAL DISLODGED. ANOTHER PORT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13096382 ↗
• MalfunctionDec 6, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PRODUCT WAS OPENED WHILE PREPARING THE TROCAR, THE HEAD PART OF OBTURATOR WAS FOUND TO BE BROKEN OFF. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934462 ↗
• MalfunctionSep 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SEAL PART OF THE DEVICE CAME OFF DURING LAPAROSCOPIC GASTRIC SLEEVE SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526328 ↗
• MalfunctionSep 9, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAST HALF OF THE LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN THE RELEASE BUTTON ON THE TOP OF THE STOP COCK WAS PRESSED WHILE USING THE TROCAR, IT CRACKED. THE PART OF THE DEVICE WAS OUTSIDE THE PATIENT'S BODY AND DID NOT DROPPED IN THE PATIENT'S ABDOMINAL CAVITY. THE DEVICE WAS CONTINUED TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451183 ↗
• MalfunctionAug 6, 2021Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC SLEEVE RESECTION BYPASS SURGERY, THERE WAS A SEVERE AIR LEAKAGE FROM THE 15 MM PORT -- IT WAS AS SEVERE AS THE PNEUMOPERITONEUM WAS UNABLE TO BE MAINTAINED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287109 ↗
• MalfunctionMar 18, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, BEFORE THE PROCEDURE, WHEN OPENING THE BOX, IT WAS NOTED THAT THE DARK BLUE OBTURATOR TOP WAS SHEARED FROM THE SHAFT. NEW SUPPLIES WERE OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515945 ↗
• MalfunctionMar 8, 2021Leak/Splash; Difficult to Remove; Detachment of Device or Device Component; Leak/Splash; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING STOMACH RESECTION, A GAS LEAK OCCURRED. WHEN THE RELOAD WAS REMOVED FROM THE PORT AFTER THE SEVENTH FIRING, THE UPPER SEAL OF THE PORT GOT PEELED OFF TOGETHER WITH THE RELOAD. ANOTHER PORT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435981 ↗
• MalfunctionFeb 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE HEAD OF OBTURATOR WAS FOUND BROKEN OFF THE MAIN BODY OF THE OBTURATOR UPON OPENING. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9749973 ↗
• MalfunctionNov 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THE TROCAR SEAL POPPED OUT/DISENGAGED THAT LEAD TO LOSS OF PNEUMOPERITONEUM. A NEW TROCAR WAS NEEDED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9377718 ↗
• MalfunctionNov 20, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, THE HEAD OF THE OBTURATOR BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9347199 ↗
• MalfunctionJun 26, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE TOP OF THE OBTURATOR BROKE OFF. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8738058 ↗
• MalfunctionJun 19, 2019Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, ON THE RETRIEVAL BAG ACCESS, THE SEAL WAS DAMAGED AND DISENGAGED OF 2 TROCARS. NEW TROCAR WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714711 ↗
• MalfunctionJun 19, 2019Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC GASTROJEJUNOSTOMY REVISION, WHEN THE TROCAR WAS BEING ACCESSED BY A TISSUE RETRIEVAL DEVICE, THE SEAL OF THE TROCAR DISENGAGED AND WAS STUCK AT THE SHAFT OF THE DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712425 ↗
• MalfunctionJun 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE INTRODUCTION OF A HAND INSTRUMENT, THE BLUE RUBBER SEAL OF THE TROCAR DISENGAGED INTO THE CAVITY OF THE PATIENT. THE SURGEON USED A GRASPER TO GRAB THE SEAL THEN PROCEEDED WITH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701238 ↗
• MalfunctionFeb 22, 2019Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN INTRODUCING THE SPECIMEN BAG, THE SURGEON NOTICED THE SEAL WAS DAMAGED AND DISENGAGED AND WAS CAUGHT IN THE CANULA. THEY OPENED A NEW TROCAR TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8363509 ↗
• MalfunctionDec 19, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, WHEN INTRODUCING THE BAG, THE SEAL WAS DAMAGED AND GOT DISENGAGED. THE SURGEON WAS ABLE TO RETRIEVE THE SEAL WITH GRASPERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8182303 ↗
• MalfunctionDec 13, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, UPON INTRODUCING THE CATCH BAG INTO THE TROCAR, THE SEAL OF THE TROCAR WAS DAMAGED AND DISENGAGED. THE DOCTOR REMOVED THE INTERNAL BLUE SEAL AFTER IT DISLODGING TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8159972 ↗
• MalfunctionOct 26, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE INSERTING A RETRIEVAL BAG, THE SEAL WAS DAMAGED. THE INTERNAL BLUE SEAL FELL INTO THE PATIENT CAVITY. THE SEAL WAS LOCATED WITH AN ENDOSCOPE AND PULLED OUT USING A GRASPER AND THE TROCAR WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8009416 ↗
• MalfunctionOct 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING INSTRUMENT EXCHANGE IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE SEAL DISENGAGED. THE INTERNAL BLUE SEAL FELL INTO PATIENT CAVITY. THE SURGEON LOCATED THE SEAL AND TOOK OUT A NEW TROCAR TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8000520 ↗
• MalfunctionSep 26, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING AN INSTRUMENT EXCHANGE ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, ALL PORTS HAD DAMAGED AND DISENGAGED SEAL. THEY OPENED NEW TROCAR TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909655 ↗
• MalfunctionSep 10, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE BEING USED FOR THE ACCESS OF THE INSTRUMENTS, THE SEAL ON THE TROCAR DISENGAGED AND WAS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7859621 ↗