Step S100710Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521090665), received between Mar 14, 2019 and Sep 20, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2021Break; Detachment of Device or Device Component; Noise, Audible; Break; Detachment of Device or Device Component; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE ENTERING THE ABDOMINAL CAVITY, THE DEVICE MADE A STRANGE NOISE. THE EXPANDABLE SLEEVE TORE AND FELL INTO THE CAVITY. TO COMPLETE THE CASE, A LAPAROSCOPIC GRASPER WAS USED TO RETRIEVE IT FROM THE CAVITY. THERE WERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12501547 ↗
• MalfunctionMar 30, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC SIGMOIDECTOMY, WHEN THE PRODUCT WAS USED, THE PORT GOT BROKE. THE PRODUCT HAD BEEN USED FOR THE PATIENT. THE SURGICAL TIME WAS EXTENDED BY LESS THAN THIRTY MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9900327 ↗
• InjuryOct 4, 2019Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, WHEN PULLING OUT THE TROCAR, IT BROKE IN HALF INTO THE PATIENT. PARTS WERE RETRIEVED. X-RAY WAS TAKEN OUT TO ENSURE NOTHING WAS LEFT IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9159128 ↗
• MalfunctionMar 14, 2019Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, WHEN THE FORCEPS WAS INSERTED DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CONVERTER FELL INTO THE ABDOMINAL CAVITY CIRCUMFERENTIALLY. THE FALLING OBJECT WAS CONFIRMED IN THE BODY AND RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8421115 ↗

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