Mini Step MS101005Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521082738), received between Nov 19, 2018 and Feb 1, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• MalfunctionFeb 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE DEVICE WAS INSERTED, A PIECE OF RUBBER SEAL DISENGAGED AND FELL INTO THE CAVITY OF THE PATIENT AND WAS ABLE TO BE PULLED OUT WITH GRASPERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277303 ↗
• MalfunctionMar 23, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC PROCEDURE, A SMALL PIECE INNER TROCAR BROKE OFF AND FELL INTO THE PATIENT CAVITY. THE HOSPITAL SAID PIECE WAS RETRIEVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 13862998 ↗
• MalfunctionMay 6, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLE, THE SEAL WAS BROKEN AND A PIECE FELL INTO THE PATIENT THAT WAS RETRIEVED WITH A GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787265 ↗
• MalfunctionNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE RUBBER CENTER TO STEP PORT FELL INTO THE PATIENT CAVITY DURING SURGICAL PROCEDURE, AND WAS THEN WAS RECOVERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084364 ↗
• MalfunctionNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE RUBBER GASKET/SEAL OF THE DEVICE DISENGAGED AND FELL INTO THE PATIENT'S CAVITY, IT WAS RETRIEVED BY USING A GRASPER. NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083992 ↗