Premium Plus CEEA 111989Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10884523006612), received between Jun 20, 2016 and Jul 23, 2024 — classified as 62 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (32 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, 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 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER PROCEDURE, WHILE PERFORMING RECTAL ANASTOMOSIS, THERE WAS POOR STAPLE FORMATION AFTER FIRING. ANOTHER CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 19813062 ↗
• MalfunctionMar 13, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN REVERSAL HARTMAN, THE STAPLER MISFIRED AND HAD AN ISSUE WITH THE SAFETY. THE DEVICE DID NOT FIRE. A STAPLER FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894971 ↗
• MalfunctionMar 7, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE CIRCULAR STAPLER DID NOT FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861543 ↗
• InjuryFeb 22, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A COLOSTOMY REVERSAL, AFTER AN OPEN ANTERIOR RESECTION, THE STAPLER CUT THE RECTUM TISSUES WITHOUT FIRING THE STAPLES. THERE WAS A BLOOD LOSS OF MORE THAN 500CC AND SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THE SURGEON MANUALLY SUTURED THE TISSUE, AND THE PROCEDURE WAS CANCELLED DUE TO THE DEVICE MALFUNCTION AND CONNECTED TO THE PREVIOUS PATH OF COLOSTOMY. THE PATIENT SHOULD HAVE STAYED IN THE INTENSIVE CARE UNIT FOR 3 TO 5 DAYS, BUT THE PATIENT WAS STILL IN THE INTENSIVE CARE UNIT AFTER SIX DAYS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 18763878 ↗
• InjurySep 1, 2023Detachment of Device or Device Component; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HEMORRHAGING POLYP BY PERFORMING AN ANASTOMOSIS. AFTER A FAILED FIRST ATTEMPT AT ANASTOMOSIS OUR PRODUCT WAS USED AND THE ANVIL WAS DETACHED AND PLACED IN THE SIGMOID COLON, THE OTHER END OF THE STAPLER WAS THEN OPENED AND THE ANVIL WAS PLACED INTO THE STAPLER IT WAS THEN CLOSED AND FIRED. THE STAPLER WAS REMOVED AND A LEAK TEST WAS PERFORMED WITH AIR AND SALINE BOTH OF WHICH SHOWED A LEAK IN THE STAPLE LINE. THE STAPLE LINE WAS THEN OVER-SEWN WITH SUTURES, RETESTED AND SHOWED NO LEAKS SO THE ABDOMEN WAS CLOSED. IT THEN WAS REPORTED THAT THE ANVIL WAS NO LONGER ON THE STAPLER, AFTER AN X-RAY CONFIRMING THAT THE ANVIL WAS STILL IN THE PATIENT A RIGID SIGMOIDOSCOPY WASUSED THE ANVIL WAS IDENTIFIED AND REMOVED THROUGH THE ANUS. AFTER REOPENING THE PATIENT FINDING THE STAPLE LINE LEAK AND ATTEMPTING ANASTOMOSES A THIRD TIME THE DOCTOR WAS UNSUCCESSFUL AND A LOOP ILEOSTOMY WAS CREATED WITH A DRAINABLE POUCH PLACED FOR STOOL. IT WAS REPORTED THAT AFTER USE, THE PATIENT EXPERIENCED LOSS OF ENJOYMENT OF LIFE, MENTAL ANGUISH, PAIN, SUFFERING, EMOTIONAL DISTRESS, PNEUMOPERITONE

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Adhesion(s); Anemia; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Aspiration/Inhalation; Blister; Cellulitis; Constipation; Discomfort; Distress; Electrolyte Imbalance; Emotional Changes; Erythema; Failure to Anastomose; Flatus; Fluid Discharge; Hyponatremia; Hypovolemia; Impaired Healing; Inflammation; Muscle Weakness/Atrophy; Nausea; Necrosis; Obstruction/Occlusion; Pain; Pneumonia; Prolapse; Purulent Discharge; Renal Failure; Scar Tissue; Sleep Dysfunction; Swelling/ Edema; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury; Urinary Retention; Vomiting

  MAUDE report 17671812 ↗
• MalfunctionAug 24, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE FIRING THE STAPLER, SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE, BUT MANUAL STAPLER DID NOT FIRE. THERE WAS DIFFICULTY REMOVING CIRCULAR STAPLER FROM CAVITY. REMOVED ASSISTED WITH ENERGY DEVICE TO SEPARATE TISSUE AND STAPLER (OTHER DEVICE TO REMOVE STAPLER FROM CAVITY). THE HANDLE WAS CHANGED AND THE SAME RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618172 ↗
• MalfunctionJun 15, 2023Misfire; Failure to Form Staple; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Misfire; Failure to Form Staple; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SIGMOIDOSCOPY, AT ANASTOMOSIS, INCOMPLETE STAPLE LINE AND HALF CUT WAS OBSERVED, MAKING THE DONUT INCOMPLETE. POOR STAPLE FORMATION WAS ALSO OBSERVED. THE STAPLER COULD NOT BE PULLED OUT SO TISSUE HAD TO BE CUT. ANOTHER STAPLER WAS TAKEN OUT BUT HAD SAME PROBLEM (INCOMPLETE STAPLE LINE AND HALF CUT), BUT WAS ABLE TO BE REMOVED NORMALLY. A THIRD STAPLER WAS USED TO ANASTOMOSE SUCCESSFULLY. SURGICAL TIME WAS EXTENDED BY AT LEAST THIRTY MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Failure to Anastomose

  MAUDE report 17134518 ↗
• MalfunctionJun 15, 2023Difficult to Remove; Misfire; Failure to Form Staple; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Misfire; Failure to Form Staple; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SIGMOIDOSCOPY, AT ANASTOMOSIS, INCOMPLETE STAPLE LINE AND HALF CUT WAS OBSERVED, MAKING THE DONUT INCOMPLETE. POOR STAPLE FORMATION WAS ALSO OBSERVED. THE STAPLER COULD NOT BE PULLED OUT SO TISSUE HAD TO BE CUT. ANOTHER STAPLER WAS TAKEN OUT BUT HAD SAME PROBLEM (INCOMPLETE STAPLE LINE AND HALF CUT), BUT WAS ABLE TO BE REMOVED NORMALLY. A THIRD STAPLER WAS USED TO ANASTOMOSE SUCCESSFULLY. SURGICAL TIME WAS EXTENDED BY AT LEAST THIRTY MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Failure to Anastomose

  MAUDE report 17134485 ↗
• MalfunctionJun 6, 2023Difficult to Remove; Mechanics Altered; Difficult to Remove; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RADICAL RESECTION OF RECTUM, WHILE ON RECTAL AND COLORECTAL ANASTOMOSIS THE KNIFE BLADE STILL CUT BUT NO STAPLES WERE FIRED. IT WAS ALSO MENTIONED THAT THE ANVIL DID NOT TILT AFTER FIRING. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE AND MAKE THE SURGERY GO SMOOTHLY.

  Patient problems: Failure to Anastomose

  MAUDE report 17073496 ↗
• InjuryMar 10, 2023Failure to Form Staple; Material Twisted/Bent; Failure to Form Staple; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RADICAL RECTAL SURGERY, WHILE ON RECTAL COLORECTAL ANASTOMOSIS, THE STAPLES DID NOT FORM COMPLETELY. IT WAS ALSO MENTIONED THAT THE ANVIL WAS BENT. THE SURGEON HAD TO OVER SEWED AND USED ANOTHER DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 16520684 ↗
• MalfunctionSep 20, 2022Difficult to Remove; Failure to Cut; Difficult to Open or Close; Difficult to Remove; Failure to Cut; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW RECTAL RESECTION, AT THE TIME OF RECTAL AND COLORECTAL ANASTOMOSIS, THE DEVICE PARTIALLY CUT THE TISSUE AND THE JAW WAS NOT ABLE TO CLOSE. THE ANVIL CANNOT BE TILTED.  A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15458993 ↗
• MalfunctionSep 14, 2022Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CANCER, DURING RECTAL ANASTOMOSIS, AFTER THE STAPLE ANVIL AND BASE WERE DOCKED, THE SURGEON SUCCESSFULLY SAW THE GREEN BAR INDICATOR WINDOW. AT THIS TIME, THE USER NEEDED TO HOLD DOWN THE FIRING AND SQUEEZED THE HANDLE TO THE MIDDLE. IT WAS FOUND THAT THE FIRING WAS NOT FIXED AND COULD BE ROTATED AT WILL RESULTING IN THE FAILURE TO FIRE AND FAIL TO SUCCEED ANASTOMOSIS. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419872 ↗
• InjuryAug 25, 2022Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING RECTAL CANCER RESECTION, AFTER ANASTOMOSIS, THERE WAS AN INCOMPLETE STAPLE LINE. IT WAS FOUND THAT SOME TISSUES WERE NOT ANASTOMOSED AND NOT COMPLETELY SUTURED. IT WAS ALSO STATED THAT THE ANVIL DOES NOT TILT AFTER FIRING. THE SURGEON HAD TO OVER SEWED USING SUTURE THREAD TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15294328 ↗
• InjuryAug 23, 2022Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL SURGERY FOR COLON CANCER, WHEN ENTEROENTERIC ANASTOMOSIS WAS PERFORMED, THE STAPLE DID NOT FORM. THE DONUTS WERE ALSO INCOMPLETE. THE STAPLE LINE WAS FIXED BY RESECTION AND RE-STAPLING. THE DOCTOR USE SUTURING UNDER LAPAROSCOPE TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15276229 ↗
• InjuryAug 10, 2022Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW RECTAL ANUS-PRESERVING PROCEDURE, WHILE IN END-TO-END RECTAL ANASTOMOSIS, THERE WAS AN INCOMPLETE STAPLE LINE. THE DEVICE PARTIALLY CUT THE TISSUE AS WELL. IT WAS NOTED THAT THE TISSUE WAS NOT STAPLED FREE FROM ANY METAL CLIPS OR SIMILAR STRUCTURES. A SECTION WAS CUT WITH A SCALPEL, AND SUTURES WERE USED TO REINFORCE THE SUTURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15202182 ↗
• MalfunctionMar 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE PACKAGING WAS OPENED, THE BOUNCING CAP WAS ALWAYS IN A BOUNCING STATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966283 ↗
• InjuryMar 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE WHITE PORTION OF THE STAPLER CAME OFF INTO THE ABDOMEN OF THE PATIENT. THE PIECE BECAME HIDDEN BEHIND THE SPLEEN AND WAS UNDETECTABLE BY FLUOROSCOPY. TO RESOLVE THE ISSUE, THE SURGEON CONVERTED TO LAPAROTOMY TO FIND THE MISSING ATTACHMENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13720368 ↗
• InjuryFeb 2, 2022Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LAR (LOW ANTERIOR RESECTION) RECTUM ANASTOMOSIS WITH COLON PROCEDURE, WHILE ANASTOMOSING THE RECTUM WITH THE COLON, THE TISSUE WAS CUT INCOMPLETELY AND THE STAPLE LINE WAS INCOMPLETE. THE SURGEON RESECTED AND REDID THE ANASTOMOSIS TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13424027 ↗
• InjuryNov 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AFTER REANASTOMOSIS OF BOWEL, WHEN DEVICE WAS REMOVED FROM THE PATIENT, THE STAFF DISCOVERED THAT THE ANVIL CAME OFF THE STAPLER. X-RAY FOUND ANVIL FELL IN THE RECTUM AND WAS SUCCESSFULLY RETRIEVED. THE SURGEON WAS CONCERNED ABOUT THE ANASTOMOSIS LEAKAGE SO REANASTOMOSIS WITH A HEALTHIER TISSUE WAS PERFORMED. CREATION OF LOOP ILEOSTOMY WAS ALSO PERFORMED TO PROTECT THE ANASTOMOSIS. HOSPITALIZATION WAS EXTENDED AS A RESULT OF THE EVENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12788563 ↗
• InjuryOct 15, 2021Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LOW ANTERIOR BOWEL RESECTION, THE FIRST STAPLER WAS FOUND PRE-FIRED (THE STAPLES WERE ALREADY EXPOSED) WHEN THE SHIPPING WEDGE WAS REMOVED. WHILE THE SECOND DEVICE WAS ABLE TO FIRE, HOWEVER, THE STAPLE LINE WAS INCOMPLETE RESULTING TO AN INCOMPLETE ANASTOMOSIS. THE SURGEON HAD TO TEAR THE ANASTOMOSIS DOWN DUE TO LEAKAGE BEFORE THE PROTECTIVE ILEOSTOMY WAS CREATED. THE INCOMPLETE STAPLE LINE WAS OVERSEWN BY THE SURGEON. WHEN THE STAPLER WAS REMOVED FROM PATIENT, THE ANVIL DISENGAGED. AN XRAY WAS DONE TO LOCATE THE COMPONENT. THE DISCONNECTED ANVIL WAS RETRIEVED USING A GRASPER UTILIZING A SIGMOIDOSCOPE. THE SURGICAL TIME AND HOSPITALIZATION WERE BOTH PROLONGED.

  Patient problems: Failure to Anastomose; Unintended Radiation Exposure; Unspecified Tissue Injury

  MAUDE report 12642453 ↗
• InjuryAug 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN BOWEL RESECTION, AFTER FIRING, THE STAPLER WAS REMOVED AND THE ANVIL DID NOT COME WITH THE DEVICE AND WAS LEFT BEHIND IN THE BOWEL AND WERE ALL RETRIEVED USING THE SURGEON'S HAND. THE PATIENT WAS SCOPED TO CHECK THE ANASTOMOSIS AND DONUTS WERE REMOVED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE ANASTOMOSIS AND DONUTS WERE INTACT AND THE DONUTS WERE REMOVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12345902 ↗
• InjuryJul 28, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS ON A LAPAROSCOPIC COLON PROCEDURE, THERE WAS A POOR STAPLE FORMATION. IT WAS STATED THAT EXCESSIVE TISSUE INCORPORATED INTO THE BARREL OF THE STAPLER. THE DONUTS WERE ALSO NOT COMPLETE. ANOTHER DEVICE AND SEWING WAS DONE TO FIX THE STAPLE LINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12239968 ↗
• MalfunctionMar 23, 2021Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554070 ↗
• InjuryFeb 26, 2021Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN LOW ANTERIOR RESECTION, UPON ANASTOMOSIS OF THE RECTUM AND ANAL CANAL, THE STAPLER DID NOT FIRE. THEN THE CIRCULAR STAPLER WAS CHANGED AND USED ANOTHER ONE WITH THE SAME LOT NUMBER BUT THIS TIME THE STAPLE LINE WAS INCOMPLETE. THE RECTUM HAD BEEN DISSECTED MORE BECAUSE OF THE STAPLER PROBLEM. ALL THE ANOSTOMOSIS AREA WAS MANUALLY SUTURED AND INCISION WAS EXTENDED. THE SURGICAL TIME WAS ALSO EXTENDED FOR ONE(1) HOUR MORE, HOSPITAL STAY WAS EXTENDED, AND AN ADDITIONAL OPERATION WAS DONE TO REPAIR THE STOMA.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11386532 ↗
• InjuryFeb 16, 2021Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, WHEN USING THE DEVICE FOR BOWEL ANASTOMOSIS ON AN OPEN ANTERIOR RECTAL RESECTION, THE DEVICE DID NOT CUT COMPLETELY. PATIENT SUFFERED FROM OOZING BLOOD AND WAS UNDER OBSERVATION. THE SURGEON MANUALLY STITCHED THE ANASTOMOSIS.

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

  MAUDE report 11333321 ↗