Step S101000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521090702), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 8819750 ↗

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