Versaport Plus 179095PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521081281), received between Mar 22, 2019 and Aug 29, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryAug 29, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC OVARIAN WEDGE RESECTION, THE CANNULA WAS BROKEN AND FELL INTO THE PATIENT'S CAVITY DURING TAKING OUT THE DEVICE FROM THE PATIENT. AN X-RAY WAS DONE TO ALLOCATE THE BROKEN PIECE. HOWEVER, THE ATTENDING PHYSICIAN AND WITH THE HELP OF GENERAL SURGEONS, UNSUCCESSFULLY SOUGHT THE PART OF THE DEVICE THAT WAS DETACHED. SURGICAL TIME WAS EXTENDED DUE TO THE PRODUCT ISSUE. THE PATIENT WENT TO RECOVERY, PRESENTING TACHYCARDIA. AS REPORTED, THE PATIENT WAS KEPT UNDER OBSERVATION FOR TWO ADDITIONAL DAYS IN THE CLINIC.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Radiation Exposure, Unintended

  MAUDE report 8947349 ↗
• MalfunctionJul 22, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE OBTURATOR/TROCAR BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8810355 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Protective Measures Problem; Adverse Event Without Identified Device or Use Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER DURING CHOLECYSTECTOMY, WHEN PLACING THE CUTTING TROCAR, THE KNIFE OF THE TROCAR HAD CUT THE PATIENT'S AORTA. THE PATIENT WAS HOSPITALIZED FOR 5 DAYS DUE TO THE ISSUE. THERE WAS BLOOD LOSS OF MORE THAN 500CC DUE TO THE PRODUCT PROBLEM. THE SURGICAL TIME WAS EXTENDED FOR 6HRS. DUE TO THE DEVICE PROBLEM.

  Patient problems: Blood Loss; Great Vessel Perforation; No Code Available

  MAUDE report 8445640 ↗