Versaport Plus NB11STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521075726), received between Nov 24, 2015 and Mar 24, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2022Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SEAL OF THE TROCAR BREAKS WHEN ENTERING INSTRUMENTS. THE PNEUMO BREAKS WHEN A UNIT WAS ENTERED.

  Patient problems: Insufficient Information

  MAUDE report 13875136 ↗
• MalfunctionApr 18, 2017Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A CHOLECYSTECTOMY, THERE WAS MISSING THE OBTURATOR TIP, THE SURGEON LOOKED FOR THE MISSING PARTS IN THE ABDOMEN BUT NOTHING WAS FOUND, AT THE END OF SURGERY AFTER TAKING OUT THE CANNULA HE FOUND THE MISSING PARTS INSIDE THE WOUND. THE SURGEON REMOVED THE PIECES FROM THE WOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6499600 ↗
• MalfunctionNov 24, 2015Component Missing; Device Contamination with Chemical or Other Material

  DURING A LAPAROSCOPIC CHOLECYSTECTOMY, A BLUE SPECK WAS NOTICED ON THE END OF THE CLIP APPLIER AND WHEN PULLED OUT OF THE TROCAR NO SPECK WAS FOUND. UNABLE TO SEE SPECK IN THE ABDOMEN. TROCAR FLUSHED WITH SALINE AND NO BLUE SPECK WAS FOUND. NO SERIOUS OUTCOME TO THE PT THAT WE HAVE IDENTIFIED AT THIS POINT IN TIME. DIAGNOSIS OR REASON FOR USE: CHRONIC CHOLECYSTITIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5253911 ↗