TA Premium 015441LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521047372), received between Dec 6, 2017 and Feb 23, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2018Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LIVER LOBECTOMY PROCEDURE, THE FIRST CARTRIDGE WAS LOADED CORRECTLY INTO THE STAPLER DEVICE, FIRED BUT THE STAPLES DID NOT COMPRESS AS THEY SHOULD HAVE. A SECOND CARTRIDGE WAS USED AND ONLY ABOUT 1/2 OF THE STAPLES FIRED CORRECTLY. SUBSEQUENTLY, ENDED UP USING A SEALING INSTRUMENT AND SUTURE TO FINISH THE LOBECTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7292190 ↗
• MalfunctionFeb 19, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LIVER LOBECTOMY PROCEDURE, THE CARTRIDGE WAS LOADED CORRECTLY INTO THE STAPLER, PLACED AND DISCHARGED, BUT THE STAPLES DID NOT COMPRESS AS THEY NORMALLY SHOULD HAVE. SUTURE AND A SEALING INSTRUMENT WERE USED TO FINISH THE LOBECTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280766 ↗
• MalfunctionDec 6, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING LOBECTOMY PROCEDURE, THE DEVICE DID NOT FIRE ON THE VESSEL. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THE PATIENT STATUS WAS REPORTED UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088257 ↗

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-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
• 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-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