N/A ECS33BRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705036022947), received between Dec 15, 2022 and Sep 17, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Failure to Fire; Appropriate Device Problem Term/Code Not Available

  It was reported that during an Sigmoid Colectomy the stapler failed to fire. Date of surgery was (b)(6) 2026. The stapler had issues with safety releasing. Then stapler would fire but did not fully staple the rectal anastomosis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801829 ↗
• MalfunctionSep 17, 2026Failure to Fire; Appropriate Device Problem Term/Code Not Available

  It was reported that during an Sigmoid Colectomy the stapler failed to fire. Date of surgery was (b)(6) 2026. The stapler had issues with safety releasing. Then stapler would fire but did not fully staple the rectal anastomosis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801825 ↗
• MalfunctionApr 25, 2024Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Firing Problem; Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION UPON FIRING OF THE DEVICE THE BREAKAWAY WASHER WAS NOT HEARD, HOWEVER THE USER FELT THAT THE HANDLE WAS PLASTIC TO PLASTIC AND COULD NOT GO ANY FURTHER. THE CONSULTANT SURGEON TOOK THE DEVICE AND FIRED THE HANDLE A SECOND TIME, PLASTIC TO PLASTIC AND THE BREAKAWAY WASHER WAS HEARD. ON REMOVING THE DEVICE THERE WERE TWO WELL FORMED COMPLETE DOUGHNUTS HOWEVER THE ANASTOMOSIS WAS INCOMPLETE AND BOWEL APPEARED TO BE 'SHREDDED' THERE WERE LOOSE MALFORMED/UNFORMED STAPLES. THE ANASTOMOSIS WAS TRANSECTED AND A NEW CIRCULAR DEVICE WAS USED WITH NO ISSUES. SURGEON CONSIDERS THIS MAYBE USER ERROR AND NOT DEVICE RELATED. THE SURGERY WAS DELAYED 120 MINUTES. NEW CIRCULAR DEVICE USED FOR ANASTOMOSIS., THE PROCEDURE WAS SUCCESSFULLY COMPLETED. EXTENDED OPERATING TIME, HOWEVER THE PATIENT HAS RECOVERED WELL WITH NO ANASTOMOTIC LEAKS OR COMPLICATIONS,

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

  MAUDE report 19180932 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. CLINICAL AND ECONOMIC OUTCOMES OF ADVANCED ENERGY DEVICES IN BREAST CANCER SURGERY: A RETROSPECTIVE ANALYSIS. ETHICON CIRCULAR STAPLER (MANUAL), PHASE I EXPLORATORY STUDY. EVALUATE THE CUMULATIVE INCIDENCE OF ANASTOMOTIC LEAKAGE AFTER CREATION OF COLORECTAL ANASTOMOSIS WITH THE ETHICON CIRCULAR STAPLER (MANUAL) ¿ A REAL WORLD DATA ANALYSIS. BLEEDING AT LEAST ONE ICD9 DX CODE FOR BLEEDING POST A PROCEDURE WITH THE USE OF THE MEGADYNE ACE BLADE. SOURCE: DIAGNOSIS CODE ICD9. REOPERATION CPT CODE + READMISSION AFTER INITIAL ATTUNE KNEE JOINT REPLACEMENT SURGERY. SOURCE: PROCEDURE CODE. SURGICAL SITE INFECTION , ICD9 DX CODE. SOURCE: DIAGNOSIS CODE ICD 9 & ICD 10. SUBSEQUENT SURGERY AT 90-DAYS SUBSEQUENT SURGERIES WERE DEFINED AS THE FIRST PRIMARY OR SECONDARY PROCEDURE CODE OCCURRING WITHIN 90-DAYS OF THE INDEX SURGERY. SOURCE: PROCEDURE CODE. THIS IS FOR ETHICON. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 19051233 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Ejection Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Ejection Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION THE END TO END ANASTOMOSIS BROKE DOWN, POSSIBLY DUE TO A MALFUNCTION OF THE CIRCULAR STAPLER. DR. THEN HAD TO PERFORM AN ILEOSTOMY.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 18455535 ↗
• MalfunctionOct 25, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18005737 ↗
• MalfunctionMay 8, 2023Delivered as Unsterile Product; Product Quality Problem; Delivered as Unsterile Product; Product Quality Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN THE CUSTOMER OPENED THE OUTER PACKAGING AND THE TYVECK PACKAGING HAD BLACK MOLD ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16889203 ↗
• InjuryApr 5, 2023Failure to Form Staple; Failure to Form Staple

  Patient problems: Insufficient Information

  MAUDE report 16681938 ↗
• MalfunctionMar 30, 2023Ejection Problem; Ejection Problem

  ATTACHED USER FACILITY MEDWATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16643476 ↗
• InjuryDec 15, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE THE DEVICE WAS FIRED. TISSUE WAS ON THE THICKER SIDE, BUT TISSUE WAS EASILY COMPRESSED TO BELOW THE MIDPOINT ON THE TISSUE COMPRESSION SCALE. STAPLER WAS FIRED BY THE PA, WHO HAS FIRED THE MANUAL CIRCULAR MANY, MANY TIMES. NO UNUSUAL SOUNDS WERE HEARD. AFTER FIRING, SURGEON NOTICED THAT THE STAPLE LINE SEPARATED. HE NOTICED NO STAPLES INTACT IN EITHER THE PROXIMAL OR DISTAL SEGMENTS OF THE TISSUE. THE KNIFE HAD BEEN DEPLOYED BECAUSE THERE WAS A CLEAN CUT OF BOTH PROXIMAL AND DISTAL SECTIONS OF TISSUE. FURTHER DISSECTION WAS DONE TO REATTEMPT THE ANASTOMOSIS. WHEN A SECOND ECS33B WAS FIRED, THE PA SHARED THAT SHE TRIED TO FIRE THE DEVICE BUT WAS UNABLE TO COMPLETE THE SQUEEZING OF THE HANDLE COMPLETELY. THE SURGEON THEN WENT "BELOW" TO COMPLETE THE FIRING. SIMILAR TO THE FIRST FIRING, THERE APPEARED TO BE NO DEPLOYED STAPLES WITH A CUTTING OF THE TISSUE. SURGEON SAID THAT THERE WERE TWO COMPLETELY CIRCUMFERENTIAL DONUTS, WITH NOT VISIBLE STAPLES ENGAGED IN THE DONUTS. THE SURGERY WAS DELAYED BY SIXTY MINUTES. A HANDSEWN ANASTOMOSIS WAS DONE, AND A TEMPORARY DIVERTING ILEOSTOMY. THE PROCEDURE WAS COMPLETED, BUT ONLY AFTER

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15986600 ↗
• InjuryDec 15, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE THE DEVICE WAS FIRED. TISSUE WAS ON THE THICKER SIDE, BUT TISSUE WAS EASILY COMPRESSED TO BELOW THE MIDPOINT ON THE TISSUE COMPRESSION SCALE. STAPLER WAS FIRED BY THE PA, WHO HAS FIRED THE MANUAL CIRCULAR MANY, MANY TIMES. NO UNUSUAL SOUNDS WERE HEARD. AFTER FIRING, SURGEON NOTICED THAT THE STAPLE LINE SEPARATED. HE NOTICED NO STAPLES INTACT IN EITHER THE PROXIMAL OR DISTAL SEGMENTS OF THE TISSUE. THE KNIFE HAD BEEN DEPLOYED BECAUSE THERE WAS A CLEAN CUT OF BOTH PROXIMAL AND DISTAL SECTIONS OF TISSUE. FURTHER DISSECTION WAS DONE TO REATTEMPT THE ANASTOMOSIS. WHEN A SECOND ECS33B WAS FIRED, THE PA SHARED THAT SHE TRIED TO FIRE THE DEVICE BUT WAS UNABLE TO COMPLETE THE SQUEEZING OF THE HANDLE COMPLETELY. THE SURGEON THEN WENT "BELOW" TO COMPLETE THE FIRING. SIMILAR TO THE FIRST FIRING, THERE APPEARED TO BE NO DEPLOYED STAPLES WITH A CUTTING OF THE TISSUE. SURGEON SAID THAT THERE WERE TWO COMPLETELY CIRCUMFERENTIAL DONUTS, WITH NOT VISIBLE STAPLES ENGAGED IN THE DONUTS. THE SURGERY WAS DELAYED BY SIXTY MINUTES. A HANDSEWN ANASTOMOSIS WAS DONE, AND A TEMPORARY DIVERTING ILEOSTOMY. THE PROCEDURE WAS COMPLETED, BUT ONLY AFTER

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15986585 ↗