Roticulator 017612Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521047693), received between Aug 22, 2017 and Feb 14, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 14, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING RETOSSIGMOIDECTOMY OPEN PROCEDURE, WHILE USING THE DEVICE ON SMALL INTESTINE, THE DEVICE DID NOT FIRE. IT WAS REPLACED BY ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8339415 ↗
• MalfunctionOct 25, 2017Break; Break

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN LOW ANTERIOR RESECTION / DOUBLE STAPLING PROCEDURE. FOR THE FIRST FIRING, THE SURGEON CLAMPED THE TISSUE OF THE RECTUM AND FULLY FIRED THE DEVICE. THEN REMOVED THE DEVICE FROM THE TISSUE, HOWEVER, NOTICED A PART OF THE JAWS WAS CRACKED. THERE WAS NO PROBLEM WITH THE STAPLING. THEN THE ANASTOMOSIS WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976393 ↗
• InjuryAug 22, 2017Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER: OCCURRED POST OPERATIVELY FOLLOWING A TOTAL COLECTOMY WITH LATERO-LATERO ILEO-RECTAL ANASTOMOSIS. THE DEVICE WAS USED TO CLOSE THE RECTUM. NO ISSUES WERE APPARENT DURING THE PROCEDURE, BUT EIGHT DAYS POST-OPERATIVELY THE PATIENT WAS ADMITTED TO THE ER. THE SURGEON DISCOVERED AN ANASTOMOTIC LEAK. TEMPORARY INJURY WAS CAUSED; THE RENAL FAILURE WAS NORMALIZED AND RESPIRATORY FAILURE IS IMPROVING. TO CORRECT THE ISSUE, THE ANASTOMOSIS WAS EXCISED AND A TERMINAL ILEOSTOMY PLACED. THE SURGEON REPORTED HE WILL ATTEMPT TO RECONSTRUCT THE TRANSIT AND REVERSE THE ILEOSTOMY. THERE WILL BE AN ADDITIONAL OPERATION TO CORRECT THE ISSUE. THE PATIENT WAS IN INTENSIVE CARE AT THE TIME OF THE REPORT. PATIENT STATUS IS ALIVE, WITH INJURY. PATIENT HAS NOW BEEN DISCHARGED FROM THE ICU. THE ILEOSTOMY HAD NOT BEEN REVERSED AS THE SURGICAL TEAM WOULD EVALUATE IF IT IS POSSIBLE TO DO IT BEFORE THE PATIENT IS DISCHARGED. PATIENT RELEVANT MEDICAL HISTORY: DIABETES, ANEURYSM OF DESCENDING THORACIC AORTA.

  Patient problems: Injury; No Code Available; Tissue Damage

  MAUDE report 6811400 ↗

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-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-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-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-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,