Premium Plus CEEA 111987Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 10884523006605), received between Apr 5, 2016 and Jan 9, 2026 — classified as 65 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 151 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER DID NOT FIRE. REPEATED ATTEMPTS TO FIRE HAVE FAILED. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026729 ↗
• MalfunctionDec 17, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRING OF THE CIRCULAR STAPLER WAS FAULTY. A NEW DEVICE OF THE SAME MODEL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831747 ↗
• MalfunctionMay 21, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, LAPAROSCOPIC RADICAL RECTAL CANCER SURGERY, WHILE ON RECTAL GASTROINTESTINAL RECONSTRUCTION, THE STAPLE WAS NOT IN FULL B CLOSURE. THE SURGEON OVERSEWED TO FIX THE STAPLE LINE.

  Patient problems: Failure to Anastomose

  MAUDE report 22064598 ↗
• MalfunctionFeb 26, 2025Failure to Fire; Expulsion; Failure to Fire; Expulsion

  IT WAS REPORTED THAT PREOPERATIVELY, THE HANDLE WAS NOT FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY. HENCE, WHILE TRYING TO FIRE, THE INSTRUMENT DID NOT FIRE AND IT PRE-FIRED. TO RESOLVE THE ISSUE, A NEW CIRCULAR STAPLER WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471698 ↗
• MalfunctionFeb 7, 2025Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE WAS PRE-FIRED. THE DEVICE COULD NOT BE FIRED. THE HANDLE COULD NOT BE FULLY SQUEEZED UNTIL IT CAME IN CONTACT WITH THE INSTRUMENT BODY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337822 ↗
• MalfunctionJan 6, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A RADICAL RESECTION OF RIGHT HEMICOLON CANCER, WHEN THE DEVICE WAS BEING APPLIED TO THE END-TO-END ANASTOMOSIS THE STAPLE LINE WAS INCOMPLETE. THE ANASTOMOTIC STOMA WAS MANUALLY SUTURED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 21081467 ↗
• MalfunctionSep 18, 2024Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248936 ↗
• MalfunctionJun 21, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL CANCER SURGERY, ON INTESTINAL ANASTOMOSIS, THE PUNCTURE DEVICE TIP CRACKED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584561 ↗
• MalfunctionJan 8, 2024Failure to Cut; Detachment of Device or Device Component; Failure to Cut; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE ANVIL OF THE DEVICE DISENGAGED INTO THE PATIENT'S CAVITY. THE ANVIL WAS REMOVED USING A SNARE. IT WAS ALSO REPORTED THAT THE ANVIL COULD NOT BE TILTED AS THE ANVIL WAS HELD UP BY TISSUE THAT WAS NOT CUT THROUGH. THE DEVICE DID NOT CUT FULLY THROUGH THE TISSUE, BUT THE STAPLE LINES OUTLINING THE DONUTS WERE INTACT. A HOT SNARE WAS USED TO LASSO AND FULGURATE THE AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 18472331 ↗
• MalfunctionDec 19, 2023Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, A COMPONENT WAS DISENGAGED AND HAD POOR BONDING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361359 ↗
• MalfunctionDec 18, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RECTAL CANCER SURGERY, DURING INTESTINAL ANASTOMOSIS, THE DEVICE PARTIALLY FIRED. THE STAPLE LINE WAS INCOMPLETE. THE SURGEON HAD TO RESECT AND RE-ANASTOMOSE THE INTESTINES TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 18348065 ↗
• MalfunctionNov 28, 2023Failure to Form Staple; Failure to Fire; Human-Device Interface Problem; Failure to Form Staple; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING COLON TUMOR RESECTION, WHEN USING AN END-TO-END STAPLER FOR ANASTOMOSIS. THE STAPLER WAS FIRED, UNABLE TO ANASTOMOSED WITH THE ANVIL TO FORM THE STAPLE HEAD AND THE STAPLES COULD NOT BE FORMED, PROLONGED THE SURGICAL TIME FOR MORE THAN 30 MINUTES. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 18219657 ↗
• MalfunctionOct 31, 2023Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTAL GASTROINTESTINAL TRACT PROCEDURE, WHEN THE DOCTOR USED AN END-TO-END STAPLER TO PERFORM INTESTINAL ANASTOMOSIS, THE STAPLER COULD NOT COMPLETELY CUT THE DIGESTIVE TRACT TISSUE AFTER THE ANASTOMOSIS, RESULTING IN INVOLVEMENT WHEN THE STAPLER WAS REMOVED THE DIGESTIVE TRACT TISSUE WAS INVOLVED AND CAUSED TEARING. THE DOCTOR IMMEDIATELY PERFORMED AN ARTIFICIAL ANASTOMOSIS ON THE TORN INTESTINE, WHICH ULTIMATELY DID NOT CAUSE MORE SERIOUS EFFECTS ON THE PATIENT.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 18044487 ↗
• MalfunctionOct 26, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL ANASTOMOSIS PROCEDURE, WHEN ANASTOMOSING THE RECTUM AND COLORECTUM, THE STAPLER DID NOT FIRE. A NEW EQUIPMENT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18015568 ↗
• MalfunctionAug 24, 2023Difficult to Remove; Failure to Cut; Difficult to Remove; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, AFTER THE FIRING OF THE DEVICE, THE ANVIL COULD BE TILTED HOWEVER, THERE WAS DIFFICULTY REMOVING THE STAPLER FROM THE CAVITY. IT WAS REPORTED THAT THE DEVICE DID NOT CUT, BUT WAS ABLE TO STAPLE, HENCE, THE DIFFICULTY IN REMOVING. AT THE SAME TIME, IT WAS REPORTED THAT A CLIP APPLIER AND TROCAR HAD A MALFUNCTION. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17617699 ↗
• MalfunctionJun 14, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE ANASTOMOTIC RECONSTRUCTION OF THE DESCENDING COLON FOR A MALIGNANT TUMOR. THE STAPLER CUT THE TISSUE, BUT THE TISSUE DID NOT SEVERE. THE CHIEF SURGEON SEVERED THE COLON AND TOOK OUT THE MUSHROOM HEAD OF THE STAPLER. AFTERWARDS, THE STAPLER WAS REPLACED, AND THE SURGERY WENT SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17129722 ↗
• InjuryMar 10, 2023Difficult to Remove; Failure to Cut; Difficult to Remove; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTUM RESECTION, WHILE RESECTING THE RECTUM, THE RELOAD WAS UNABLE TO LOAD INTO THE HANDLE AND THE CIRCULAR STAPLER DID NOT CUT THE TISSUE AND THE ANVIL DID NOT TILT AFTER FIRING. A SIZER AND A NEW MANUAL HANDLE WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16521942 ↗
• InjuryDec 8, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION (LAP LAR), THE LINEAR STAPLER WAS NOT ABLE TO LOAD. THE CLIP APPLIER HANDLE COULD BE SQUEEZED BUT THE CLIPS WAS NOT LOADING PROPERLY. THERE WAS DIFFICULTY REMOVING THE CIRCULAR STAPLER FROM THE CAVITY. THE DOCTOR HAD TO USE A BLADE TO SEPARATE THE TISSUE. TO COMPLETE THE CASE, A NEW LINEAR STAPLER HANDLE, CIRCULAR STAPLER AND CLIP APPLIER WERE USED.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15941822 ↗
• InjuryOct 14, 2022Failure 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 A LAPAROSCOPIC LOW ANTERIOR RECTAL RESECTION AND ANASTOMOSIS PROCEDURE, THE ANASTOMOTIC STOMA KEPT BLEEDING AFTER THE DEVICE WAS FIRED; THE ANASTOMOSIS AND THE STAPLE FORMATION WAS POOR. THE SURGEON PERFORMED ADDITIONAL SUTURING, BUT THE BLEEDING PERSISTED. THE ENDOSCOPY DEPARTMENT WAS THEN INVITED FOR FURTHER CONSULTATION. THE BLEEDING POINT WAS THEN FOUND AND ADDITIONAL SUTURING WAS DONE TO STOP THE BLEEDING AND COMPLETE THE SURGERY. THIS LED TO OVER 120ML BLOOD LOSS AND 2-HOUR EXTENDED SURGICAL TIME.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15607260 ↗
• MalfunctionOct 13, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLORECTAL SURGERY, IN DETACHING THE BOWEL, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601240 ↗
• InjurySep 14, 2022Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC LOW RECTAL CANCER SURGERY, DURING END-TO-END ANASTOMOSIS OF THE RECTUM, THE END-TO-END STAPLER CUT OF THE RECTUM WAS INCOMPLETE. THE STAPLER PARTIALLY CUT THE TISSUE. IT WAS STATED THAT THE DEVICE WAS APPLIED OVER A PREVIOUS STAPLE LINE. ADDITIONAL SUTURING WAS PERFORMED WITH THE SUTURE, AND PATCHED UP THE INTESTINAL TUBE LEAKAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15421539 ↗
• InjuryJul 22, 2022Device Slipped; Failure to Fire; Mechanics Altered; Positioning Problem; Device Slipped; Failure to Fire; Mechanics Altered; Positioning Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW PROCTECTOMY, WHEN ANASTOMOSING WITH THE COLON, THE DEVICE FIRED BUT NO STAPLES WERE DEPLOYED. THERE WAS AN UNUSUAL EFFORT REQUIRED TO TURN THE TWIST KNOB IN ORDER TO VISUALIZE THE GREEN BAR. THE DEVICE WAS DIFFICULT AND WAS UNABLE TO CLOSE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 15089500 ↗
• InjuryJul 18, 2022Mechanics Altered; Insufficient Device Problem Information; Mechanics Altered; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING RECTAL CANCER RESECTION, STAPLER FIRED AND CUTTING WAS COMPLETED BUT NO STAPLES CAME OUT. AFTER TAKING IT OUT, THE STAFF AND MEDICAL STAFF TRIED TO FIRE THE STAPLER AGAIN, AND THERE WERE INDEED NO STAPLES. THE CUTTING POSITION WAS NOT TOO LOW, AND THERE WAS STILL A LOT OF TISSUE THAT COULD BE FIRED AND ANASTOMOSED AGAIN WITH THE STAPLER, SO THE DOCTOR USED A NEW END-TO-END STAPLER TO PERFORM THE INCISION AND ANASTOMOSIS AGAIN. THE PATIENT HAD EXCESS NORMAL TISSUE REMOVED.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15043372 ↗
• InjuryJul 16, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTAL CANCER RESECTION, WHILE DOING END-TO-END ANASTOMOSIS OF THE TWO STUMPS, WHEN DEVICE WAS FIRED, CUTTING OPERATION WAS PERFORMED BUT NO STAPLES CAME OUT. A NEW END-TO-END STAPLER WAS REOPENED IN TIME AND MORE NORMAL TISSUES OF THE PATIENT WERE CUT FOR ANASTOMOSIS. SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15036587 ↗
• InjuryMay 20, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL RESECTION FOR LOW RECTAL CANCER, WHEN COMPLETING THE ANASTOMOSIS, THE JAWS WERE UNABLE TO BE OPENED TO REMOVE FROM TISSUE. THE ANASTOMOSIS COULD NOT BE EXITED AFTER SAFE FIRING. THE SURGEON INSPECTED THE ANASTOMOSIS, THEN USED SCISSORS TO CUT THE INVOLVED PORTION AND THEN REMOVED THE STAPLER.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 14463175 ↗