Step S110000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20884521090849), received between Nov 17, 2017 and Dec 25, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K961940); they may or may not involve this specific model.

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.

• MalfunctionDec 25, 2025Break; Break

  IT WAS REPORTED THAT PREOPERATIVELY OF LAPAROSCOPIC GASTROPEXY, THE JAWS OF THE TWO CLIP APPLIERS WOULD NOT OPEN ALL THE WAY AND WOULD NOT FIRE. ADDITIONALLY, THE CANNULA BROKE FOR BOTH THE PORTS. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892194 ↗
• MalfunctionDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR ACUTE APPENDICITIS, WHILE INSERTING THE LAPAROSCOPIC PORTS, THE SHORT VERESS NEEDLE HAD BEEN REPLACED WITH A SUBSTITUTION NEEDLE THAT WAS LONGER THAN WHAT WAS NORMALLY USED. THE NEEDLE HIT THE PATIENT'S INNER ABDOMEN AND CAUSED AN INTRAMURAL HEMATOMA OF THE SIGMOID COLON. AFTER REPAIRING, THE COLON WAS INSPECTED DIRECTLY; THERE WAS NO FULL-THICKNESS INJURY. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES.

  Patient problems: Hematoma

  MAUDE report 20919450 ↗
• MalfunctionDec 18, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN PACKAGED OPENED, NEEDLE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346278 ↗
• MalfunctionJun 29, 2021Break; Break

  ACCORDING TO THE REPORTER, THE CANNULA BROKE WHEN THE DEVICE WAS OPENED. THIS HAPPENED PRIOR TO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085405 ↗
• MalfunctionNov 13, 2019Difficult to Insert; Noise, Audible; Difficult to Insert; Noise, Audible

  ACCORDING TO THE REPORTER DURING A PEDIATRIC LAPAROSCOPIC ABDOMINAL PROCEDURE, BOTH DEVICE MADE A STRANGE NOISE, AND THERE IS SOME PROBLEM INSERTING THE OBTURATOR INTO THE SLEEVE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9315318 ↗
• MalfunctionJul 23, 2019Break; Break

  ACCORDING TO THE REPORTER, WHILE INSERTING THE TROCAR THROUGH THE ABDOMINAL WALL DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON WOULD INSERT THE NEEDLE, BUT COULD NOT REMOVE IT BECAUSE IT WAS TOO TIGHT. IT WAS ALSO REPORTED THAT THE NEEDLE WAS TOO BIG FOR THE SHEATH. TWO OTHER SEPARATE SHEATHS WERE BROUGHT, BUT BOTH WERE RIPPED/BUCKLED IN WHEN IT WAS ATTEMPTING TO REMOVE THE NEEDLE. THE SURGEON PERSISTED WITH THE TROCARS TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8819741 ↗
• MalfunctionNov 17, 2017Bent; Break; Bent; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC GONADECTOMY PROCEDURE. UPON INSERTION INTO THE BODY, THE NEEDLE BENT. THE CANNULA BROKE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THE SURGEON USED ANOTHER NEEDLE WITH THE SAME ANGLE, FORCE, AND TECHNIQUE AND IT WORKED FINE. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7040506 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961940. One submission often covers many models, so check the product and lot details in each record.

• Z-1387-2023 · Mar 1, 2023 · Open, Classified
  Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010