ETHICON EC3D60SRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705036043522), received between Oct 31, 2025 and Sep 30, 2026 — classified as 3 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (21 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 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  Patient problems: Insufficient Information

  MAUDE report 50952435 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose

  MAUDE report 50952413 ↗
• MalfunctionSep 30, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951674 ↗
• MalfunctionSep 30, 2026Positioning Failure; Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951637 ↗
• MalfunctionSep 30, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951598 ↗
• MalfunctionSep 30, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951570 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that, following a gastric bypass procedure, the patient experienced postoperative mesenteric bleeding and was transferred to the intensive care unit. The patient has remained in rehabilitation since 9/15. Additional information has been requested.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50947440 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922980 ↗
• MalfunctionSep 28, 2026Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916991 ↗
• MalfunctionSep 25, 2026Failure to Form Staple

  It was reported that during an unknown surgery, it was observed that 5-6 staples were malformed at the 1st firing. The device was used on gastric body. The cartridge color was Green. Another competitive 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 50898415 ↗
• MalfunctionSep 20, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834827 ↗
• MalfunctionSep 20, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834826 ↗
• MalfunctionSep 20, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834825 ↗
• MalfunctionSep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a Robot assisted unknown surgery, arterial bleeding occurred after stapling the gastric body. Hemostasis was performed with additional suture. After that, oozing and staple malformation were observed when performing a gastric-duodenal anastomosis using a device with a different lot. There was no effect on the patient. There was no blood transfusion performed. The cartridge color was Blue. Additional suture was performed to complete the case. No additional information provided.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823663 ↗
• MalfunctionSep 17, 2026Failure to Fire; Difficult to Open or Close; Activation Problem

  It was reported that during a Liver Resection procedure, it was observed that the stapler got stuck on tissue. It also wouldn't fire or open jaw with battery in place or manually. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803400 ↗
• MalfunctionSep 17, 2026Material Integrity Problem; Ejection Problem

  It was reported that during an unknown procedure, the cartridge loaded without issue at the 1st firing. The cartridge broke and came off when the cartridge was taken off after firing. Since it was difficult to take off, the gauze was placed at the base of the jaws and the principle of leverage could be used. The cartridge could not be loaded when loading the cartridge at the 2nd firing. Another device was used to complete the case. There were no adverse consequences to the patient. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802970 ↗
• MalfunctionSep 1, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541881 ↗
• MalfunctionAug 31, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520395 ↗
• MalfunctionAug 28, 2026Failure to Form Staple; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501564 ↗
• MalfunctionAug 26, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459565 ↗
• MalfunctionAug 25, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50433968 ↗
• MalfunctionAug 19, 2026Failure to Form Staple; No Apparent Adverse Event

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

  MAUDE report 50327527 ↗
• MalfunctionAug 6, 2026Difficult or Delayed Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160324 ↗
• MalfunctionAug 4, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132753 ↗
• MalfunctionAug 3, 2026Material Integrity Problem; Ejection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114665 ↗