VersaStep VSR100005Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521084209), received between Apr 16, 2018 and Aug 18, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 18, 2021Break; No Device Output; Break; No Device Output

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY, THE DEVICE CANNULA BROKE, IT WAS REPORTED THAT THE STEP RUPTURED DURING TROCAR INSERTION. ALSO, THE INSULATION NEEDLE DID NOT "CLICK" DURING INSERTION. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336035 ↗
• MalfunctionDec 18, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHILE PERFORMING INSERTION OF THE CANNULA INTO THE ABDOMINAL WALL, THE TROCAR FELL OUT AND DAMAGE TO THE EXPANDABLE SLEEVE WAS FOUND OUT. AS REINSERTION AND PLACEMENT COULD NOT BE PERFORMED, A NEW PRODUCT WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037490 ↗
• MalfunctionOct 7, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGY PROCEDURE, THE PORT CAME OFF WITH THE FORCEPS MANY TIMES. THE EVENT OCCURRED IN USE FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162732 ↗
• MalfunctionApr 27, 2018Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC EXCISION OF LESION OF UTERUS, IT WAS NOT TOO SMOOTH WHEN INSERTING THE DILATOR INTO THE OUTER SHEATH OF THE DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469387 ↗
• MalfunctionApr 16, 2018Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, SURGICAL DEVICES OR INSTRUMENTS LIKE FORCEPS COULD NOT BE TAKEN IN AND OUT SMOOTHLY THROUGH THE TROCAR. THE CUSTOMER IS USING A LAPAROSCOPIC HANDSET AND A VESSEL SEALING DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7433086 ↗