Versaport ONBFCA12STRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521181328), received between Aug 25, 2017 and Dec 11, 2017 — classified as 4 malfunctions.

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

• MalfunctionDec 11, 2017Detachment Of Device Component; Device Packaging Compromised; Detachment Of Device Component; Device Packaging Compromised

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY PROCEDURE, THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT. THE RUBBER WAS ALSO PERFORATED BY PASSING THE CLIPPER BY THE TROCAR. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7105342 ↗
• MalfunctionNov 1, 2017Device Packaging Compromised; Device Packaging Compromised

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC RECTOSIGMOIDECTOMY PROCEDURE. THE SEAL OF THE PORT WAS DAMAGED. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, OPENED A NEW CANNULA. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994467 ↗
• MalfunctionAug 25, 2017Detachment Of Device Component; Device Packaging Compromised; Detachment Of Device Component; Device Packaging Compromised

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A LAPAROSCOPIC PROCEDURE, THE DEVICE¿S LENS DISENGAGED AND THE SEAL BROKE. THEY OPENED A NEW 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 6821594 ↗
• MalfunctionAug 25, 2017Difficult to Insert; Device Packaging Compromised; Difficult to Insert; Device Packaging Compromised

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC PROCEDURE. THE TROCAR SEAL BROKE AT THE CLIPPER'S INTRODUCTION. THE SEAL WAS DAMAGED FOR BOTH DEVICES. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, OPENED A NEW TROCAR AND CANNULA. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6821160 ↗