Roticulator 017619Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521047730), received between Nov 6, 2017 and Aug 5, 2022 — classified as 4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2022Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL RIGHT PNEUMONECTOMY PROCEDURE, WHILE RESECTIONING THE MAIN PULMONARY VEIN, THE SURGEON SET THE DEVICE ON THE TISSUE, SQUEEZED THE HANDLE, AND NOTED THAT THE JAWS WERE ABLE TO CLOSED. BUT WHILE FIRING THE DEVICE, THE HANDLE COULD NOT BE SQUEEZED. THE JAWS WERE OPENED AND IT WAS CONFIRMED THAT THE TISSUE WAS NOT STAPLED. THE COLLECTED PRODUCT SEEMED TO HAVE BEEN FIRED, BUT IT IS UNKNOWN AT WHICH STEP THE FIRING WAS ABLE TO BE PERFORMED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180116 ↗
• InjuryNov 7, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, THE DEVICE FAILED TO CLOSE THE STAPLES AFTER CLOSING THE PROCEDURE DURING AN OPEN INTRAPERICARDIAL PNEUMONECTOMY. THE DEVICE WAS USED FOR TRUNK CLOSURE OF THE RIGHT PULMONARY ARTERY. THE ISSUE WAS RESOLVED BY SUTURING. THIS RESULTED TO EXTENDED SURGICAL TIME, INTRAOPERATIVE HEMORRHAGE WITH TOTALLY OPEN PULMONARY ARTERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels; Unspecified Tissue Injury

  MAUDE report 12758927 ↗
• InjurySep 23, 2020Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LIGATION OF THE LOWER RIGHT PULMONARY VEIN ON AN OPEN PULMONARY LOBECTOMY, THE STAPLES DID NOT DEPLOY PROPERLY AND REMAINED OPEN, AND IT LED TO A BLEEDING. THE SURGEON HAD TO CLAMP AND SUTURE THE VEIN. THIS RESULTED TO TISSUE DAMAGE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10572005 ↗
• InjurySep 16, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PULMONARY LOBECTOMY, WHEN STAPLING THE UPPER LEFT PULMONARY VEIN, AN ABNORMAL SOUND WAS HEARD WHEN STAPLING. THE DEVICE DID NOT FIRE AND 300 CC BLOOD LOSS WAS OBSERVED. EMERGENCY CLAMPING AND SUTURE WAS PERFORMED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 10543994 ↗
• InjuryJun 18, 2020Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN OPEN LIVER TRANSPLANT PROCEDURE, WHILE PERFORMING RESECTION OF THE SUPRAHEPATIC, THE SURGEON WAS ABLE TO PERFORM FULL COMPLETE SQUEEZES OF THE HANDLE, HOWEVER THE DEVICE ONLY STAPLED A LINE OF STAPLES AND THERE WAS AN INCOMPLETE STAPLE LINE WHICH WAS FIXED BY OVER SEWING. A CLAMP WAS USED TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 10166155 ↗
• MalfunctionFeb 3, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PULMONARY ARTERY TOTAL PNEUMONECTOMY RESECTION, THE REPORTED DEVICE WAS USED FOR THE FIRST FIRING, BUT THE STAPLES WERE FIRED IN U SHAPE WITHOUT BEING FORMED IN B SHAPE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8300549 ↗
• MalfunctionMay 2, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VATS (VIDEO-ASSISTED THORACIC SURGERY) LOBECTOMY, THE DEVICE DID NOT FIRE. THE SURGICAL TEAM PROVIDED LITTLE INFORMATION EXCEPT THAT IT DID NOT STAPLE/FIRE PROPERLY. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THE SURGICAL TEAM OPENED A NEW STAPLER WHICH PERFORMED AS EXPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7480083 ↗
• MalfunctionNov 6, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER: DURING A LUNG LOBECTOMY, BEFORE CLAMPING THE DEVICE OVER TISSUE, THEY WERE UNABLE TO OPEN THE JAWS OF THE DEVICE. ANOTHER DEVICE HAD BEEN USED. THE LAST KNOWN PATIENT STATUS IS WELL.

  Patient problems: No Information

  MAUDE report 7003932 ↗

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-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-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-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