VersaOne FCSPASS (UDI 10884521678705)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521678705), received between Apr 8, 2020 and Mar 30, 2021 — classified as 5 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 18, 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.

• MalfunctionMar 30, 2021Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, ON A ROBOT-ASSISTED LAPAROSCOPIC PROCEDURE, DURING PREPARATION, THE UPWARD AND DOWNWARD MOVEMENTS OF THE INSTRUMENT INSIDE THE DEVICE WERE HINDERED EVEN WHEN THE STOPPER SCREW ON THE DEVICE WAS LOOSENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590631 ↗
• MalfunctionFeb 12, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE'S SEAL WAS DAMAGED. IN ADDITION, IT WAS FOUND THAT THE STOPPER PORTION THAT SHOULD NORMALLY BE TIGHTENED WHEN IT IS APPLIED COULD NOT BE TIGHTENED AND FELL OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321187 ↗
• MalfunctionSep 11, 2020Difficult to Remove; Packaging Problem; Difficult to Remove; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY PROCEDURE, WHEN USING THE DEVICE, IT GOT CAUGHT IN THE PERITONEUM AND GOT BENT. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10520404 ↗
• MalfunctionAug 31, 2020Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE DEVICE BROKE. JAWS WERE UNABLE TO CLOSE WHEN RELEASING THE RINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10470422 ↗
• MalfunctionApr 8, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE CLOSING THE TROCAR SITE, THE SURGEON TRIED TO OPEN THE JAW OF THE DEVICE BUT IT WAS BROKEN. THE DEVICE WAS CHANGED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9934385 ↗