VersaOne B5STSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521539846), received between Aug 30, 2017 and Jul 17, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, DURING INSERTION OF THE TROCAR, THE TIP CRUMBLED, AND BLUE PIECES REMAINED ON THE WALLS OF THE PATIENT'S BELLY. BECAUSE PLASTIC DEBRIS WAS EXTRAPERITONEAL AND SCATTERED, IT CANNOT BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22536129 ↗
• MalfunctionMar 13, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, IT WAS IMPOSSIBLE TO INSERT THE TROCAR IN TO THE PATIENT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899248 ↗
• InjuryJul 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DEVICE COMPONENTS FELL INTO THE CAVITY OF THE PATIENT. INTRA-ABDOMINAL VISUALIZATION SHOWED SMALL BLUE FRAGMENTS AND PRESENCE OF SCRATCHES ON THE PLASTIC AT THE TROCAR ORIFICE. ABUNDANT WASHING WAS PERFORMED TO RESOLVE THE ISSUE. THE EVENT LED TO EXTENDED OPERATING TIME.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10260414 ↗
• MalfunctionAug 30, 2017Difficult to Remove; Device Packaging Compromised; Difficult to Remove; Device Packaging Compromised

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC HYSTERECTOMY. THE VESSEL SEALING DEVICE CAUSED THE INSUFFLATION MACHINE TO ALARM DUE TO LACK OF FLOW THROUGH THE TROCAR. THE SEAL OF THE PORT WAS DAMAGED. THE TROCAR BECAME STUCK ON THE SUCTION IRRIGATOR AND WHEN THEY WERE PULLED APART, THE INTERNAL SEAL OF THE TROCAR BROKE. TO CORRECT THE ISSUE, THE SURGICAL TEAM HAD TO SWITCH THE GAS TUBE FROM ONE TROCAR TO ANOTHER EACH TIME THE VESSEL SEALING DEVICE WAS PASSED BETWEEN THEM. A SECOND TROCAR WAS USED WHEN THE SUCTION IRRIGATOR WAS STUCK INSIDE THE TROCAR. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6831881 ↗