RoticulatorRecalls & reported problems across all models

We found 4 models of Roticulator by Covidien LP in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2017 and Apr 20, 2023 — classified as 15 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Roticulator problems

Roticulator models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Roticulator 017614

  STAPLE, IMPLANTABLE
  35 reports
• Roticulator 017619

  STAPLE, IMPLANTABLE
  8 reports
• Roticulator 017617

  STAPLE, IMPLANTABLE
  7 reports
• Roticulator 017612

  STAPLE, IMPLANTABLE
  3 reports

Recent Roticulator adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2023Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING THE ROBOTIC TO OPEN ILEOSTOMY TAKEDOWN, DIAGNOSTIC LAP, EXTENSIVE LYSIS OF ADHESIONS. THE SURGEON ENGAGED THE STAPLER AND TRIED TO RELEASE IT FROM THE TISSUE, BUT IT WOULD NOT RELEASE. THE FIRST ASSIST CALLED THE REP FOR TROUBLESHOOTING HELP, BUT STILL COULD NOT GET IT TO RELEASE. THE SURGEON ENDED UP USING A DIFFERENT STAPLER AND HAD TO CUT THE TISSUE JUST ABOVE WHERE THE OTHER STAPLER WAS STUCK TO BE ABLE TO REMOVE IT FROM THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16779027 ↗
• 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 ↗
• MalfunctionSep 1, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS NOT ABLE TO FIRE. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406512 ↗
• MalfunctionAug 6, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE STAPLER DID NOT FIRE. THE DEVICE WAS ALSO ARRIVED WITHOUT PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288984 ↗
• MalfunctionOct 7, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED TO CUT AND ANASTOMOSED THE LARYNGEAL TISSUE DURING AN OPEN LARYNGECTOMY, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10645617 ↗
• MalfunctionSep 23, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RADICAL RESECTION OF RECTAL CANCER, THEN THE USER CLOSED THE DISTAL RECTUM, THE HANDLE WAS FULLY SQUEEZED BUT THE DEVICE DID NOT FIRE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10573732 ↗
• 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 ↗
• InjuryJul 23, 2020Failure to Form Staple; Difficult to Open or Close; Failure to Form Staple; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE FOR RECTAL CANCER, THERE WAS NO STABILITY IN THE STAPLE LINE AND THE STAPLES DID NOT FORM INTO B-SHAPE AFTER FIRING. THE DEVICE WAS DIFFICULT OR UNABLE TO CLOSE. THE STAPLE LINE WAS OVERSEWN TO FIX THE STAPLE FORMATION ISSUE AND COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THE PATIENT HAD UNDERGONE CHEMOTHERAPY AND RADIATION TREATMENTS.

  Patient problems: No Code Available

  MAUDE report 10317532 ↗
• 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 ↗
• InjuryDec 17, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACOTOMY PROCEDURE, AFTER THE DEVICE WAS CLAMPED OVER THE TISSUE, THE JAWS WERE UNABLE TO BE OPENED AND REMOVED FROM THE TISSUE. A BIGGER RESECTION OF THE LUNG TISSUE USING A TA STAPLER WAS DONE TO RESOLVE THE ISSUE THAT LEAD TO UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9480487 ↗
• InjuryNov 25, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTUM CELIO CONVERSION PROCEDURE, DURING FIRING THE SURGEON CUT THE RECTUM THINKING STAPLES HAD BEEN DEPLOYED, BUT UPON OPENING IT WAS NOTED THAT THERE WAS NONE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S HOSPITAL STAY WAS EXTENDED FOR 15 DAYS. THE SURGEON LOST ESTIMATED 2.5 CM OF TISSUE ON THE DISTAL PART OF THE RECTUM AND THERE WAS TISSUE DAMAGE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9371861 ↗
• MalfunctionJun 27, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER FAILED. AFTER USE OF THE PRODUCT ACCORDING TO GUIDELINES DESCRIBED BY THE MANUFACTURER, COMPLETE STAPLING FAILED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738113 ↗
• InjuryJun 21, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, THE JAWS WOULD NOT OPEN AFTER THE DEVICE WAS CLAMPED OVER TISSUE, THEY USED FORCEPS FOR CUTTING AND RELEASING THE DEVICE AND THE ANATOMIC PART. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE DUE TO THE COMPLICATION OF THE SURGERY AND THE NEED FOR ONE MORE SURGEON.

  Patient problems: No Code Available

  MAUDE report 8722773 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall