N/A (REF NB5STF)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825016555), received between May 11, 2017 and May 11, 2017 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K062497); 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.

• MalfunctionMay 11, 2017Break

  IT WAS REPORTED THE TROCAR BROKE IN HALF AT THE BASE DURING THE PROCEDURE. NOTHING FELL INTO THE PATIENT AND THE DEVICE WAS EASILY REMOVED AND REPLACED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6562182 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062497. One submission often covers many models, so check the product and lot details in each record.

• Z-0498-2019 · Jun 19, 2018 · Terminated
  Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consi
• Z-0765-2017 · Nov 11, 2016 · Terminated
  Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients re