ETHICON EC3D60CRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705036043539), received between Jan 8, 2026 and Sep 30, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952215 ↗
• MalfunctionSep 28, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916879 ↗
• MalfunctionSep 1, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543916 ↗
• MalfunctionAug 20, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50349960 ↗
• MalfunctionJun 22, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, MALFORMED STAPLES WERE OBSERVED ON THE RESECTED TISSUE FORM THE FIRST OR SECOND FIRING. THE MALFORMED AREA WAS REPAIRED WITH BURIED SUTURES, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580472 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, THE STAPLE LINE WAS BLEEDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25432446 ↗
• MalfunctionMay 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A THORACOSCOPIC LUNG RESECTION PROCEDURE, ETHICON 4000 WITH A GREEN CARTRIDGE WAS USED ON THE LEFT LOWER BRONCHUS. WHEN CHECKING THE STAPLE LINE, SIX MALFORMED STAPLES (APPROXIMATELY 80-90%) WERE OBSERVED AT THE 2D STAPLE LINE ON THE MAIN BRONCHUS SIDE OF THE STUMP. THE STAPLES FORMED IN A U-SHAPE AND WERE CONSIDERED NOT TO HAVE CONTACTED THE ANVIL. ADDITIONAL SUTURING AND REINFORCEMENT WITH MEDIASTINAL FAT TISSUE WERE PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT CONDITION AFTER SURGERY WAS STABLE. THE CARTRIDGE COLOR WAS GREEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318396 ↗
• MalfunctionMay 12, 2026Failure to Form Staple

  IT WAS REPORTED THAT THE DEVICE WAS USED THE PREVIOUS DAY AND MISFIRED, WITH IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE MISFIRED AS A FEW STAPLES WERE STICKING STRAIGHT OUT AND NOT FORMING A CURVED SHAPE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150060 ↗
• MalfunctionApr 13, 2026Failure to Form Staple

  IT WAS REPORTED THAT THORACIC SURGEON AND PA WERE COMPLETING VATS WEDGE RESECTION USING EC3D60C. WHEN FIRING ACROSS THE PARENCHYMA USING ER60G, THEY NOTICED THE STAPLES WERE NOT PROPERLY FORMED AND APPEARED AS QUILL-LIKE PROTRUDING EXTERNALLY FROM THE TISSUE. THEY DID NOT FIRE ACROSS EXISTING STAPLE LINES WHEN IT OCCURRED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24864390 ↗
• MalfunctionMar 11, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THEY HAD FIRED THE DEVICE 8-9 TIMES AND ON THE LAST FIRING, THE STAPLES LOOKED LIKE A V SHAPE. THE SURGEON SAID THEY FELT LIKE THE STAPLE LINE WAS IN TACT, SO NO PATIENT HARM, BUT WAS STILL VERY UNSETTLING. THE SURGEON BELIEVED THERE WERE ABOUT 6 THAT LOOKED LIKE THE V SHAPE AT THE DISTAL END OF THE JAWS. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574452 ↗
• MalfunctionMar 3, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, IT WAS OBSERVED THAT THE INNER STAPLE LINE DID NOT FORM APPROPRIATELY. THE STAPLES WERE STICKING OUT, AND THE SURGEON HAD TO OVER SEW THE STAPLE LINE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495911 ↗
• MalfunctionJan 8, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT ACTIVATE WHEN THE SURGEON ATTEMPTED TO FIRE IT. THE RELOAD WAS THEN REPLACED, AND THE STAPLER FUNCTIONED PROPERLY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010393 ↗