VersaOne B5SHFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521539815), received between May 9, 2017 and Jan 10, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY THE B5SHF BLADED 5 MM SHT FIX TROCAR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129542 ↗
• MalfunctionOct 27, 2023Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A DIAGNOSTIC LAPAROSCOPIC ORCHIDOPEXY WHILE INSERTING THE TROCAR THE SURGEON GRABBED IT WITH GRASPING FORCEPS AFTER THAT IT WAS NOTICED THAT THERE WERE WAS A BLUE STAIN ON THE PATIENT PERITONEUM WHICH WAS CONFIRMED TO BE PIECES OF THE DEVICE. THEY WERE ABLE TO RETRIEVE THE PIECES. THE INSTRUMENT WAS CHECKED AND IT WAS FOUND THAT THERE WERE SCRATCHES ON THE BLUE PART OF THE TROCAR. THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE AS A RESULT OF THE ISSUE. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Tissue Breakdown

  MAUDE report 18023052 ↗
• MalfunctionSep 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING APPENDECTOMY, WHEN INSERTING TROCAR, THE EXTREMITY (LENS) DETACHED FROM THE TROCAR, LEAVING PIECES IN THE PATIENT'S CAVITY. THE INCISION HAD TO BE EXTENDED AND PIECES WERE REMOVED BEFORE CONTINUING WITH THE OPERATION. SURGERY WAS EXTENDED BY THREE MINUTES AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 17703174 ↗
• InjuryFeb 12, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING THE INSERTION OF THE TROCAR IN A LAPAROSCOPIC APPENDECTOMY, THE CANNULA BROKE, BLUE TROCAR PARTICLES WERE DISSEMINATED IN THE PATIENT'S ABDOMINAL CAVITY, THE PARTICLES WERE ASPIRATED BUT COULD NOT BE RECOVERED IN THEIR ENTIRETY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8331284 ↗
• InjuryApr 30, 2018Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE OBTURATOR OR THE TROCAR BROKE AND FELL INTO THE CAVITY OF THE PATIENT. THE PLASTIC EXTREMITY CRUMBLED AWAY AND ALL PLASTIC FRAGMENTS WERE NOT RETRIEVED. A NEW TROCAR WAS USED TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7472198 ↗
• MalfunctionApr 24, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A COELIO APPENDECTOMY, WHEN INTRODUCING THE TROCAR INTO THE PATIENT'S ABDOMEN, THE PROTECTIVE TIP OF THE TROCAR BLADE CRACKED AND SEVERAL SMALL PIECES OF PLASTIC FELL INTO THE PATIENT'S STOMACH. THEY WERE RECOVERED BY THE SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7456072 ↗
• MalfunctionMay 9, 2017Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY PROCEDURE THE OBTURATOR/TROCAR BROKE. ALSO, THE PHYSICIAN WAS USING AN ATRAUMATIC INSTRUMENT TO GRASP THE TIP OF THE TROCAR TO ASSIST WITH INSERTION. DURING THIS STAGE, THREE SMALL FRAGMENTS OF TIP FELL INTO ABDOMEN THAT WERE SUBSEQUENTLY RETRIEVED USING SUCTION-IRRIGATION DEVICE. TO COMPLETE THE PROCEDURE, A SECOND TROCAR WAS INSERTED. THERE WAS NO HARM CAUSED TO THE PATIENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553480 ↗