Roticulator 017617Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521047723), received between Oct 2, 2017 and May 9, 2019 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING OPEN LEFT UPPER LOBECTOMY PROCEDURE, AFTER THE BRONCHUS WAS TRANSECTED AND THE STAPLER RELEASED, IT WAS NOTED THAT THE STAPLE LINE APPROXIMATION WAS INCOMPLETE. THERE WERE STAPLES THAT DID NOT COMPRESS AND STAYED IN THE U FORMATION. STAPLE LINE WERE FIXED BY RESECTION AND RE-STAPLING. A NEW STAPLER WAS OPENED AND WERE ABLE TO SUCCESSFULLY STAPLE ACROSS THE BRONCHUS.

  Patient problems: No Code Available

  MAUDE report 8596368 ↗
• MalfunctionMar 28, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A LEFT UPPER LOBECTOMY WHEN ISOLATING THE LUNG TISSUE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS NOT ABLE SQUEEZE THE HANDLE AND THEREFORE THE LAPAROSCOPIC STAPLER DID NOT FIRE. THE PROCEDURE WAS CONVERTED TO OPEN PROCEDURE AND 2 OPEN STAPLERS OF THE SAME LOT WAS USED HOWEVER THERE WAS POOR STAPLE LINE FORMATION, THE STAPLE LINE WAS SCATTERED AND UNFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 8462379 ↗
• MalfunctionMar 28, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A LEFT UPPER LOBECTOMY WHEN ISOLATING THE LUNG TISSUE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS NOT ABLE SQUEEZE THE HANDLE AND THEREFORE THE LAPAROSCOPIC STAPLER DID NOT FIRE. THE PROCEDURE WAS CONVERTED TO OPEN PROCEDURE AND 2 OPEN STAPLERS OF THE SAME LOT WAS USED HOWEVER THERE WAS POOR STAPLE LINE FORMATION, THE STAPLE LINE WAS SCATTERED AND UNFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8462367 ↗
• InjuryNov 21, 2018Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACOTOMY UPPER AND MIDDLE LOBECTOMY PROCEDURE, THE DEVICE FIRED BUT DID NOT DEPLOY ANY STAPLES. TO RESOLVE THE ISSUE THE SURGEON SUTURED THE BRONCHUS TO CLOSED.

  Patient problems: No Code Available

  MAUDE report 8094863 ↗
• MalfunctionOct 22, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING AN OPEN LOBECTOMY, THE JAWS DID NOT OPEN AND GOT STUCK AFTER THE DEVICE WAS CLAMPED OVER TISSUE. THE JAWS WERE FORCED WITH A PAIR OF PLIERS TO OPEN THEM AND PROCEEDED TO CUT WITH A COLD KNIFE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7991056 ↗
• MalfunctionMay 1, 2018Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LOWER ANTERIOR RESECTION, WHILE PERFORMING RESECTION OF COLON, THE STAPLES OF THE DEVICE DID NOT DEPLOY. THEY TOOK ANOTHER DEVICE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7476094 ↗
• InjuryOct 2, 2017Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, THE DEVICE DID A POOR STAPLE FORMATION. THE LAPAROSCOPIC PROCEDURE WAS THEN CONVERTED TO AN OPEN DUE TO THE DEVICE PROBLEM. STAPLE LINE WAS OVER SEWED. THEY CHANGED THE STAPLER FOR A NEW ONE TO COMPLETE THE CASE. PATIENT IS ALIVE.

  Patient problems: No Code Available

  MAUDE report 6907596 ↗

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-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-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-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-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,