Mini Step MS101008Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521082745), received between Nov 13, 2018 and Jan 3, 2024 — classified as 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PEDIATRIC APPENDECTOMY, A PIECE OF THE RUBBER REDUCER SEAL DETECTED AND WAS FOUND IN THE BODY CAVITY AND WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436950 ↗
• MalfunctionSep 30, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, DURING EXCHANGE OF INSTRUMENTS, THE RING SHAPE OF THE TROCAR BROKE OFF AND DISLODGED IN THE PATIENT. THE SURGEON WAS ABLE TO USE A GRASPER TO PICK THE COMPONENT OUT OF THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520257 ↗
• MalfunctionApr 25, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SURGEON STATED THAT THE INSUFFLATION NEEDLE WAS DIFFICULT TO ENGAGE/MOVE FORWARD INTO THE DILATOR. IT WAS FELT THAT IT GETS STUCK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8552548 ↗
• MalfunctionNov 26, 2018Break; Break

  ACCORDING TO THE REPORTER, THE SHEATH RIPPED WHEN THE SURGEON PULLED OUT THE VERRESS NEEDLE, NOT REALLY A DAMAGED SEAL BUT A RIPPED SHEATH. IT WAS REPLACED WITH A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101643 ↗
• MalfunctionNov 13, 2018Break; Break

  ACCORDING TO THE REPORTER, WHILE THE DEVICE WAS BEING APPLIED TO THE ABDOMINAL WALL DURING CATHETER INSERTION IN A LAPAROSCOPIC PROCEDURE, THE CANNULA BROKE. THE SURGEON INSERTED THE NEEDLE INTO THE RADIALLY EXPANDABLE SLEEVE AFTER INSUFFLATION. THE SLEEVE AND NEEDLE WERE INSERTED NORMALLY INTO THE PATIENT TO DEPLOY THE SLEEVE, BUT THE SLEEVE ESSENTIALLY WAS STUCK TO THE NEEDLE AND BUCKLED OR BUNCHED UP AS THE SURGEON ATTEMPTED TO REMOVE THE NEEDLE. THEY TRIED USING TWO OTHER UNITS OF THE SAME LOT BUT SIMILAR STICKING MALFUNCTION OCCURRED. THEY USED ANOTHER DEVICE OF THE SAME LOT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8067908 ↗