Step S100705Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521090658), received between Jul 18, 2018 and Sep 11, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN USED TO BE CONNECTED TO INSUFFLATION TUBING, THE SMALL BLUE PIECE BROKE WHEN USING THE TROCAR. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195365 ↗
• MalfunctionJun 8, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PECTUS NUSS PROCEDURE, THE CANNULA BROKE INTO TWO PIECES AND FELL INTO THE PATIENT¿S CAVITY. THE SURGEON RETRIEVED THE BROKEN PIECES FROM THE PATIENT¿S CHEST LAPAROSCOPICALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11961965 ↗
• MalfunctionNov 19, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC OOPHORECTOMY, AT THE HEAD AND THE WELDED PART OF THE OUTER CYLINDER, IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083839 ↗
• MalfunctionJul 18, 2018Break; Material Fragmentation; Detachment of Device or Device Component; Material Split, Cut or Torn; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC THORACOSCOPY, UPON INSERTING THE CAMERA THROUGH THE PORT, DEBRIS WAS SEEN INSIDE THE THORACIC CAVITY. PIECES OF DEBRIS WERE SUCCESSFULLY REMOVED, BUT AS THE CAMERA OR OTHER INSTRUMENTS CONTINUED TO BE INSERTED THROUGH THE PORT, MORE DEBRIS WAS NOTED. IT WAS DECIDED BY THE DOCTORS THAT THE DEBRIS WAS COMING FROM THE PORT SO IT WAS REMOVED FROM THE PATIENT. AS THE CAMERA WAS REMOVED, IT APPEARED THAT THE INSIDE OF THE PORT'S CANNULA WAS "RIPPED UP" AND THAT IS WHERE THE PIECES OR DEBRIS WERE COMING FROM. ANY DEBRIS VISUALIZED DURING THE THORACOSCOPY WERE REMOVED BY THE DOCTOR AND HIS TEAM TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7700904 ↗

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