N/A ECS21BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705036022916), received between Dec 9, 2021 and Apr 5, 2024 — classified as 2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 19049973 ↗
• MalfunctionNov 29, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THEY GOT READY TO FIRE, ONCE FIRED STAPLES DIDN'T DEPLOY AND IT DID NOT CUT DURING A ROBOTIC SIGMOID. THEY HAD TO USE ANOTHER STAPLER TO COMPLETE CASE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231832 ↗
• MalfunctionJul 5, 2023No Apparent Adverse Event; Ejection Problem; No Apparent Adverse Event; Ejection Problem

  IT WAS REPORTED THAT DURING THE ROBOTIC GASTRIC BYPASS PROCEDURE THE DEVICE WAS DEFECTIVE AT THE ANVIL CAUSING A HOLE IN THE ANASTOMOSIS. THE HOLE WAS REPAIRED WITH SUTURE.

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

  MAUDE report 17263714 ↗
• MalfunctionJun 2, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A JEJUNAL ESOPHAGUS MECHANICAL ANASTOMOSIS, AFTER TOTAL GASTRECTOMY, THE DEVICE DID NOT CUT NOR SUTURE. NO AE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051020 ↗
• MalfunctionApr 14, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS THE SURGEON ADJUSTED APPROPRIATE TENSION, BUT IT DIDN'T FEEL RIGHT BUT WAS IN THE GREEN AREA. IT CUT TISSUE COMPLETELY BUT DIDN'T STAPLE ALL THE WAY AROUND. HE GOT A NEW DEVICE AND FIRED AT A DIFFERENT LOCATION TO COMPLETE THE ANASTOMOSIS. NO PATIENT HARM BUT MAY HAVE SMALLER THAN NORMAL STOMACH POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744088 ↗
• MalfunctionNov 28, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE GASTRIC BYPASS PROCEDURE, THE DEVICE WAS FIRED BY THE DOCTOR. AFTER FIRING, THE STAPLER WOULD NOT RELEASE. THE DOCTOR THAN RETIRED THE DEVICE A SECOND TIME AND BREAKAWAY WASHER WAS HEARD. WHEN STAPLER WAS RELEASED, SURGEONS CLAIMED ¿THE POSTERIOR PART OF THE ANASTOMOSIS HELD AND ABOUT 90% FELL APART WITH UNFORMED STAPLES. THE SURGEON THEN USED A LINEAR STAPLER TO COMPLETE ANASTOMOSIS AND PERFORMED A LEAK TEST. LEAK TEST WAS NEGATIVE, AND PATIENT IS RECOVERING WELL. THE SURGERY WAS DELAYED. UNKNOWN OF HOW LONG. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT SEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869184 ↗
• MalfunctionApr 15, 2022Failure to Fire; Failure to Fire

  USER FACILITY MW (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117436 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS POST OPERATIVE BLEEDING FROM CIRCULAR ANASTOMOSIS AT THE GJ DURING A GASTRIC BYPASS PROCEDURE. PATIENT WAS BROUGHT BACK TO OR THE FOLLOWING DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vomiting

  MAUDE report 12970018 ↗