Versaport Plus NB8STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521073951), received between Jan 29, 2018 and Dec 20, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE SURGEON INSERTED THE TROCAR AD TIP BROKEN INSIDE THE PATIENT FACIA SKIN. SURGEON WAS ABLE TO RETRIEVED THE BROKE PIECE. SURGEON HAD TO MAKE THE INCISION LARGER BUT NOT MORE THAN 1 INCH THAT CAUSES TISSUE DAMAGED IN ORDER TO GET THE BROKEN TIP OF TROCAR OUT OF THE PATIENT. NEW TROCAR WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 8187267 ↗
• MalfunctionDec 3, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, DURING THE INSERTION OF THE TROCAR, THE TIP OF THE TROCAR (OBTURATOR) BROKE OFF AND MADE A STRANGE NOISE. THEY OPENED A NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8126660 ↗
• MalfunctionJan 29, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGY CASE, THE DEVICE BROKE. THEY TOLD THAT WHILE INSERTING THE DEVICE, A WHITE PIECE OF PLASTIC CAME OUT OF THE TIP IN THE FASCIA. 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 7225251 ↗