VersaOne B5SHSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521539822), received between May 18, 2018 and Mar 25, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• InjuryMar 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, BLUE PLASTIC FLAKES WERE OBSERVED TO BE RELEASED WHEN THE TROCAR WAS INTRODUCED. THE PARTICLES COULD NOT BE REMOVED DUE TO THEIR SIZE OF THE DISPERSION BETWEEN THE SKIN AND THE PERITONEUM AND IN THE MEMBRANES OF THE MESENTERY FLAKING OFF THE WALLS. THE PATIENT WILL BE MONITORED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11568387 ↗
• MalfunctionNov 19, 2018Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, AT THE END OF THE PROCEDURE, THE DEVICE SEAL WAS DAMAGED. A LITTLE OF SEAL FELL INTO THE CAVITY OF THE PATIENT AND WAS RECOVERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8086341 ↗
• MalfunctionAug 23, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, THE DEVICE HAD A DAMAGED VALVE. A LITTLE PIECE OF THE VALVE FELL INTO PATIENT CAVITY BUT WAS RETRIEVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7809644 ↗
• MalfunctionMay 18, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE HAD A DAMAGED SEAL AND A LITTLE PLASTIC OF THE VALVE FELL IN. THE LITTLE PLASTIC HAS BEEN RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7526011 ↗