TA Premium 015427LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521047358), received between Nov 2, 2018 and Nov 2, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Form Staple” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K855047); 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 18, 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.

• InjuryNov 2, 2018Loss of or Failure to Bond; Misfire; Failure to Form Staple; Loss of or Failure to Bond; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING PNEUMONECTOMY, THE DEVICE WAS PARTIALLY FIRED AND THERE WAS A POOR STAPLE FORMATION. AFTER THE SUR GICAL PROCEDURE DURING THE BRONCHOSCOPY, PHYSICIAN FOUND OUT THAT STAPLER LINE WAS PARTIALLY OPEN. THE PATIENT WAS UNDER 24 HOUR OBSERVATION AND CURRENTLY HOSPITALIZED AT THE INTENSIVE CARE DEPARTMENT.

  Patient problems: No Code Available

  MAUDE report 8033205 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K855047. One submission often covers many models, so check the product and lot details in each record.

• Z-1848-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection,
• Z-1844-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection,
• Z-1847-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection
• Z-1845-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection
• Z-1846-2012 · May 9, 2012 · Terminated
  Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection