Step S100000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884521090825), received between Sep 27, 2017 and Mar 31, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT DURING THE START OF A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR WHILE BEING USED TO INSUFFLATE THE ABDOMEN, THE INSUFFLATION NEEDLE WENT INTO THE MESENTERY AND INSUFFLATED IT A LITTLE. TISSUE DAMAGE WAS OBSERVED. THE SURGEON ALLEGED THAT THE NEEDLE DID NOT MAKE A SOUND WHEN ENTERING THE PATIENT, AND THAT THIS LACK OF AUDIBLE SOUND CAUSED THE NEEDLE TO BE INSERTED TOO FAR, WITH MESENTERIC INSUFFLATION OCCURRING. THE CASE WAS REPORTED TO HAVE CONTINUED, AND NO ADDITIONAL OPERATION WAS PLANNED.

  Patient problems: Tissue Breakdown

  MAUDE report 24746819 ↗
• MalfunctionSep 11, 2024Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN OPENING THE PACKAGE, THE USER FOUND OUT THAT THE STOPCOCK DETACHED FROM THE TOP PORTION OF THE PORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191712 ↗
• MalfunctionSep 14, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGIC PROCEDURE, WHEN UNPLUGGING THE PORT, THE CANNULA OF THE DEVICE RUPTURED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745620 ↗
• MalfunctionMar 16, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SPRING WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551958 ↗
• MalfunctionJan 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STOPCOCK BROKE. THE TOP FELL OFF OF THE INSUFFLATION NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094422 ↗
• MalfunctionMay 13, 2021Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, THERE WAS AN ABNORMAL FEELING OF BEING CAUGHT WHEN TRYING TO PUNCTURE. THE DEVICE WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 11820694 ↗
• MalfunctionNov 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY, PART OF THE FIRST DEVICE WHICH SHOULD NOT BE DISENGAGED, WAS FOUND TO BE DISENGAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9376765 ↗
• MalfunctionApr 25, 2019Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, PREOPERATIVELY, 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 8552544 ↗
• MalfunctionFeb 22, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, UPON EXITING OR INSERTING INTO THE PATIENT, THE TIP OF THE NEEDLE BROKE OFF. IT ENDED UP INSIDE OF THE PATIENT¿S BODY BUT THE SURGEON WAS ABLE TO RETRIEVE IT AND REMOVE IT FROM THE PATIENT USING GRASPERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8364673 ↗
• MalfunctionSep 27, 2017Dull, Blunt; Packaging Problem; Dull, Blunt; Packaging Problem

  ACCORDING TO THE REPORTER, DURWHILE ACCESSING THE SKIN, THE TIP OF THE PRODUCT WAS NOT SHARP AND THE CANNULA WAS BROKEN. A NEW PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6897718 ↗

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