CONTOUR CS40BRecalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10705036012399), received between Nov 28, 2017 and Apr 16, 2026 — classified as 1 death, 14 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (31 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 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Failure to Fire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER JAMMED WHEN THE SURGEON TRIED TO FIRE IT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897358 ↗
• InjuryFeb 9, 2026Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE UNK OPERATION, A SITUATION OCCURRED THAT IS DIFFICULT TO EXPLAIN: AFTER TRANSECTION OF THE RECTUM BELOW THE STAPLE LINE, THE RECTUM WAS OPEN. (NORMALLY, THE CONTOUR STAPLER PLACES STAGGERED STAPLE ROWS ON BOTH SIDES OF THE BOWEL AND DIVIDES IT BETWEEN THE STAPLE LINES. TECHNICALLY, IT SHOULD NOT BE POSSIBLE FOR THE REMAINING RECTUM TO BE OPEN.) THE UNEXPECTED SITUATION RESULTED IN THE INABILITY TO CREATE A NEW ANASTOMOSIS BETWEEN THE COLON AND THE RECTUM. CONSEQUENTLY, THE PATIENT MUST LIVE PERMANENTLY WITH A STOMA.

  Patient problems: Pneumothorax

  MAUDE report 24292744 ↗
• InjuryApr 29, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION THAT THE STAPLER MISFIRED(DID NOT STAPLE THE BOWEL) DURING A BOWEL CASE.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925865 ↗
• MalfunctionFeb 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PRODUCT MALFUNCTION.NO PATIENT-RELATED RESULTS HAVE BEEN IDENTIFIED AT THE TIME OF COMPLAINT RECOGNITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343875 ↗
• MalfunctionOct 1, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN THE SURGEON FIRED THE SINGLE-USE STAPLER DURING PATIENT¿S OPEN BOWEL SURGERY, THE STAPLER WOULD NOT RELEASE FROM THE TISSUE. THE SURGEON WAS REQUIRED TO EXTEND THE INCISION INTO THE MESENTERY TO REMOVE THE DEFECTIVE STAPLER; THIS RESULTED IN A LACERATION OF THE PATIENT¿S SIGMOID COLON. SURGEON REPAIRED THE DEFECT WITH SUTURES. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20343789 ↗
• MalfunctionFeb 23, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CARTRIDGE SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772352 ↗
• MalfunctionFeb 5, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646574 ↗
• MalfunctionJan 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PIN DOES NOT WORK. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508563 ↗
• MalfunctionNov 9, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CONTOUR STAPLER FIRED STAPLES PROPERLY, BUT DID NOT CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18106733 ↗
• MalfunctionOct 30, 2023Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN OPEN SIGMOIDECTOMY, THE KNIFE RAN BUT THE STAPLE DID NOT DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029663 ↗
• MalfunctionMay 30, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN ANTERIOR RESECTION, THE DEVICE COULD NOT BE FIRED WHEN THE DEVICE WAS USED ON THE RECTUM DISARTICULATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17023998 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT SURGERY FOR A 9 YEAR HISTORY OF COLITIS AND ULCERATIVE COLITIS REQUIRING MAXIMIZING MEDICAL THERAPY AND REQUIRING ESSENTIALLY CONTINUOUS STEROID BOLUSES. PATIENT UNDERWENT A PLANNED 3-STAGE PROCEDURE WITH A TOTAL ABDOMINAL COLECTOMY, J POUCH PLACEMENT, AND DIVERTING LOOP ILEOSTOMY. SURGEON NOTED CHRONIC INFLAMMATORY CHANGES AROUND THE ENTIRE COLON, CONSISTENT WITH ACTIVE COLITIS. OPERATIVE NOTE STATES SURGEON DIVIDED THE TERMINAL ILEUM WITH A ¿GIA 100 STAPLING DEVICE¿ ACROSS THE ASCENDING AND TRANSVERSE COLON. SURGEON ALSO NOTED FORMED STOOL AND SIGNIFICANT INFLAMMATORY CHANGES AROUND THE ENTIRE COLON DESPITE PATIENT UNDERGOING MECHANICAL AND ANTIBIOTIC BOWEL PREP. SURGEON USED A ¿CONTOUR STAPLING DEVICE¿ TO STAPLE ACROSS THE DISTAL BOWEL, AND THEN A CLAMP-AND-TIE TECHNIQUE ACROSS THE MESORECTUM. NO DIFFICULTIES NOTED WITH USE OF THE STAPLER, ADEQUATE HEMOSTASIS WAS ENSURED, AN END ILEOSTOMY ALONG THE RIGHT ABDOMINAL WALL WAS PERFORMED AND AN INCISIONAL WOUND VAC WAS PLACED. THE PATIENT WAS DISCHARGED ON POD 5. A FEW DAYS LATER, THE PATIENT DEVELOPED ABDOMINAL PAIN AND CT SCAN REVEALED DEHISCENCE OF THE SUTURE LINE OF THE PROXIMAL RECTAL POUCH AND PATIENT UNDERW

  Patient problems: Adhesion(s); Failure to Anastomose

  MAUDE report 16993805 ↗
• MalfunctionApr 12, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE USER COULD NOT FINISH THE FIRING SEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724353 ↗
• MalfunctionFeb 1, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING EXPLORATORY LAPAROTOMY BOWEL RESECTION, WHEN THEY WENT TO STAPLE THE BOWEL THE DEVICE WOULDN'T PRIME. CASE COMPLETED WITH LIKE DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277180 ↗
• MalfunctionOct 18, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DIDN'T PROPERLY CLOSE (DIFFICULT TO CLOSE). THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626685 ↗
• MalfunctionJul 25, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, AFTER NEW RELOAD WAS INSERTED, DEVICE COULD NOT BE CLOSED AND FIRED. SURGERY COMPLETED WITH NEW DEVICE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094122 ↗
• MalfunctionJun 17, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY, THE TRIGGER COULD NOT BE GRASPED SO THAT THE DEVICE COULD NOT BE FIRED BEFORE THE 1ST FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14731382 ↗
• MalfunctionJun 14, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, WHEN FIRING THE CONTOUR STAPLER, THE PRE-LOADED CARTRIDGE CUT THE TISSUE, BUT THE STAPLES DIDN¿T FORMED. SO, THE SURGEON REQUESTED ANOTHER CARTRIDGE AND IT WORKED PROPERLY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES TO INCLUDE NO DAMAGE TO THE PATIENT. PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685647 ↗
• MalfunctionJun 6, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE FOR THE ESOPHAGUS, THE STAPLES COULD NOT BE DEPLOYED WHEN THE TLC75 WAS USED AT THE 4TH FIRING. WHEN THE CS40B WAS USED, THE STAPLE FORMATION DID NOT LOOK AS USUAL TOO. THE DEVICES WERE USED FOR THE GASTRIC TUBE FORMATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601123 ↗
• MalfunctionApr 18, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE WHEN TRYING TO DEPLOY THE STAPLES THE HANDLE BROKE. NO FRAGMENTS WERE GENERATED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14134603 ↗
• MalfunctionApr 8, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE ANTERIOR COLON RESECTION THE STAPLER CUT BUT IT DID NOT STAPLE. A NEW DEVICE WAS USED TO OVER SEW AND COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053015 ↗
• InjuryMar 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE THAT THE SURGEON STRUGGLED WITH HOW TO USE AND HOW TO FIRE THE DEVICE AND THAT IT DIDN¿T FIRE ¿CORRECTLY¿, AND PATIENT RECEIVED A COLOSTOMY.

  Patient problems: Insufficient Information

  MAUDE report 13904656 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE COLORECTAL PROCEDURE, THE SURGEON FIRED A CONTOUR STAPLER FOR THE SECOND TIME. WHEN THE SURGEON OPENED THE DEVICE, THE DEVICE HAD CUT BUT NO STAPLES WERE LAID DOWN. THERE WAS OTHER MEDICAL INTERVENTION AND WAS UNABLE TO CONFIRM IF THE DEVICE WAS PROPERLY RELOADED BETWEEN FIRINGS. THE SURGERY WAS DELAYED BY 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892721 ↗
• InjuryMar 24, 2022Difficult to Insert; Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE COLORECTAL PROCEDURE, THE SURGEON FIRED A CONTOUR STAPLER FOR THE SECOND TIME. WHEN THE SURGEON OPENED THE DEVICE, THE DEVICE HAD CUT BUT NO STAPLES WERE LAID DOWN. THERE WAS OTHER MEDICAL INTERVENTION AND WAS UNABLE TO CONFIRM IF THE DEVICE WAS PROPERLY RELOADED BETWEEN FIRINGS. THE SURGERY WAS DELAYED BY 10 MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892704 ↗
• MalfunctionMar 24, 2022Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  IT WAS REPORTED DURING A COLORECTAL PROCEDURE, THE 2ND FIRING OF AN ECHELON CONTOUR STAPLER MISFIRED. IT LAID STAPLES CORRECTLY BUT DID NOT TRANSECT THE TISSUE. SURGEON TRANSACTED TISSUE WITH NO ISSUE. NO OTHER INFORMATION WAS PROVIDED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892371 ↗