Roticulator 017614Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10884521047709), received between Aug 21, 2017 and Apr 20, 2023 — classified as 7 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (14 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 25 most recent of 35 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 5, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A RECTAL NEOPLASIA, WHEN CLAMPING THE INTESTINE, THERE WAS A COMPLETE FAILURE IN STAPLING, THE DEVICE WAS ABLE TO FIRE, HOWEVER THE STAPLES WERE NOT ABLE TO FORM A B-SHAPE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672732 ↗
• MalfunctionJun 4, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN RADICAL GASTRECTOMY, ON STOMACH PYLORUS, THE SURGEON WAS ABLE TO PERFORM FULL, COMPLETE SQUEEZES OF THE HANDLE BUT THE DEVICE DID NOT FIRE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666359 ↗
• InjuryMay 31, 2019Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN TUMOR RESECTION PROCEDURE, WHILE USING THE DEVICE TO CLOSE THE INTESTINE BY GOING DOWN THE DISTAL OF THE TUMOR WHICH WAS LOCATED ON THE RECTUM, THE STAPLE LINE WAS INCOMPLETE AND THERE WAS POOR STAPLE FORMATION. THE STAPLES FELL INTO THE CAVITY OF THE PATIENT AND IT WAS RETRIEVED WITH SUCTION/IRRIGATION DEVICE. RESECTING AND RE-STAPLING USING NEW DEVICE WAS DONE TO FIXED THE STAPLE LINE.

  Patient problems: No Code Available

  MAUDE report 8660722 ↗
• MalfunctionMay 20, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN LOWER RECTAL RESECTION, WHILE PREPARING THE RELOAD FOR FIRING, THE DEVICE WAS STUCK, RESULTING THE RELOAD BEING UNABLE TO FIRE. THE PRODUCT WAS CHANGED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626304 ↗
• MalfunctionMar 25, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, DURING INTESTINAL STAPLING, THE STAPLES DID NOT DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8447667 ↗
• InjuryMar 12, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING INTESTINAL RECONSTRUCTION IN OPEN SIGMOID RESECTION, THE DEVICE PARTIALLY FIRED. IN ORDER TO COMPLETE THE CASE, REMOVAL OF STAPLES THAT DID NOT CLOSE WITH MANUAL SUTURING WAS PERFORMED.

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

  MAUDE report 8412689 ↗
• MalfunctionMar 7, 2019Sharp Edges; Sharp Edges

  ACCORDING TO THE REPORTER, DURING A COLOSTOMY TAKEDOWN PROCEDURE, AFTER FIRING THE STAPLER, THE SURGEON OPENED THE JAWS OF THE STAPLER AND THE HANDLE SNAPPED BACK (THE JAWS SPRING OPENED RAPIDLY) AND CUTS AND CREATED A BLOOD BLISTER ON HIS FINGER. THE ISSUE WAS RESOLVED BY SURGEON BANDAGING HIS OWN FINGER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8398792 ↗
• MalfunctionJan 15, 2019Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING AN OPEN RECTOSIGMOIDECTOMY PROCEDURE, WHILE STAPLING IN THE MEDIUM STRAIGHT AND IRRADIATED STRAIGHT FABRIC, THE STAPLER FAILED TO COMPLETE THE CLOSURE AND WITH THE RESISTANCE IT BROKE. THE DEVICE WAS DIFFICULT OR UNABLE TO CLOSE AND THE CLOSING LEVER BROKE. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8248534 ↗
• MalfunctionJan 2, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCTECTOMY PROCEDURE, ON STAPLING PHASE, THE STAPLER DID NOT FIRE. IT WAS ENABLE TO STAPLE ON THE RECTUM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8209092 ↗
• MalfunctionNov 26, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER: DURING AN OPEN SIGMOIDECTOMY, THE STAPLER DID NOT FIRE. NO PATIENT INJURY. TO COMPLETE THE PROCEDURE, A NEW DEVICE WAS OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8102179 ↗
• MalfunctionNov 8, 2018Misfire; Failure to Fire; Misfire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE WAS FIRED, THEN STOPPED IN THE DISTAL AREA AFTER THE FIRST SHOT. THEY OPENED ANOTHER NEW STAPLER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8050955 ↗
• MalfunctionJun 21, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION SURGERY, THE DEVICE DID NOT FIRE. THEY USED ANOTHER STAPLER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625028 ↗
• MalfunctionApr 10, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LOWER ANTERIOR RESECTION, WHILE CLOSING THE RECTUM, THE JAWS WERE UNABLE TO BE OPENED TO BE REMOVE FROM TISSUE. THE DEVICE WAS PRIED OFF USING ADDITIONAL TOOL AND USED ANOTHER INSTRUMENT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7419413 ↗
• MalfunctionApr 10, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A RECTOSIGMOIDECTOMY PROCEDURE, WHILE CLOSING THE RECTUM, THERE WAS AN INCOMPLETE STAPLE LINE. THE STAPLER WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7412255 ↗
• InjuryMar 26, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION (LAR) PROCEDURE. THE STAPLING DEVICES WERE BEING USED FOR THE RECTUM RESECTION. THE PATIENT HAD UNDERGONE RADIATION TREATMENTS SO THE TISSUE WAS VERY THICK. THE PATIENT WAS ALSO OBESE WITH A VERY NARROW PELVIS. THE POWERED STAPLING HANDLE BROKE DUE TO THE THICKNESS OF THE RECTUM. THE SURGEON FORCED THE TRIGGER PUSHING INTENSIVELY. THERE WAS ALSO A PROBLEM UNLOADING THE POWERED STAPLING DEVICE. SEEMS AS IF THE AXIS IS OUTSIDE THE ADAPTER DUE TO THE EXTREME FORCE THE SURGEON DID TRY TO PLACE AND FIRE THE STAPLER WITH THE RELOAD. A COMPONENT OF THE INNER ADAPTER AXIS BROKE OFF. THEN TRIED TO PERFORMED WITH RESECTION USING A MANUAL STAPLING HANDLE WITH ANOTHER RELOAD, BUT IT DID NOT WORK EITHER. THEN TRIED WITH A ROTICULATOR STAPLER, BUT THE STAPLE LINE WAS NOT CONTINUOUS. WAS NOT SAFE TO USE A CIRCULAR STAPLER IN ORDER TO PERFORM THE ANASTOMOSIS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 7371847 ↗

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-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-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-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-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,