Versaport ONB11STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521181397), received between Aug 24, 2017 and Sep 19, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE INNER TROCAR WAS ATTEMPTED TO BE REMOVED, IT DID NOT DETACH FROM THE REST OF THE DEVICE. IT WAS STUCK AND REQUIRED THE USE OF SURGICAL INSTRUMENTS TO GET IT FREE IT.

  Patient problems: Insufficient Information

  MAUDE report 17775520 ↗
• MalfunctionOct 30, 2020Difficult to Insert; Detachment of Device or Device Component; Packaging Problem; Difficult to Insert; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PROCEDURE, THE DEVICE WAS INSERTED INTO MID-ABDOMEN, HALF-WAY THROUGH THE PROCEDURE, THE SURGEON WAS STRUGGLING TO GET A LAPAROSCOPIC INSTRUMENT THROUGH THE BLUE VALVE IN THE TROCAR. THIS CAUSED TO A TINY PART OF THE BLUE SEAL TO BREAK OFF AND FALL DOWN THE TROCAR, LANDING INSIDE THE CAVITY OF THE PATIENT. THE DOCTOR RETRIEVED THE BROKEN PIECE USING A LAPAROSCOPIC GRASPER THEN THE TROCAR WAS REMOVED AND REPLACED WITH ANOTHER KIND OF TROCAR. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10764313 ↗
• MalfunctionMay 16, 2018Detachment Of Device Component; Device Packaging Compromised; Detachment Of Device Component; Device Packaging Compromised

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE DEVICE HAD A DAMAGED SEAL ON ALL PORTS. AT THE END OF THE SURGERY, THEY FOUND A BLUE PIECE TORN FROM THE DEVICE THAT FELL IN THE CAVITY OF THE PATIENT. IT WAS REPORTED THAT A LOT OF TIME WAS WASTED TRYING TO FIND OUT IF THERE WERE MORE PIECES BEFORE THEY COMPLETED THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7519787 ↗
• MalfunctionMay 9, 2018Detachment Of Device Component; Leak/Splash; Detachment of Device or Device Component; Detachment Of Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AFTER THE TROCAR WAS SUCCESSFULLY INSERTED AND WHEN THE OBTURATOR WAS REMOVED THE INNER DUCK BILL SEAL CAME OUT WITH THE OBTURATOR. AIR OR GAS LEAKED FROM THE SEAL. A NEW 11MM TROCAR WAS OPENED AND USED SUCCESSFULLY TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7499532 ↗
• MalfunctionAug 24, 2017Device Packaging Compromised; Device Packaging Compromised

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A LAPAROSCOPIC PROCEDURE, THE DEVICE¿S CLIPPER BROKE AND THE SEAL WAS DAMAGED. THEY USED AN NEW DEVICE TO COMPLETE THE CASE AND RESOLVED THE ISSUE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6818479 ↗