ETHICON ER60GRecalls & reported problems
Ethicon Endo-Surgery, LLC · ETHICON 3D RELOAD 60MM GREEN · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705036040798), received between Oct 29, 2025 and Jun 2, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (3 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.
Reports received per month
Most reported problems
Device problems
- Failure to Form Staple3
- Failure to Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING A ROBOTIC PANCREATODUODENECTOMY, THE STOMACH WAS TRANSECTED USING TWO GREEN CARTRIDGE FIRINGS. MALFORMED STAPLES WERE OBSERVED FREQUENTLY ON THE FIRST FIRING. IT WAS DIFFICULT TO DETERMINE WHETHER THERE WERE MALFORMED STAPLES ON THE SECOND FIRING BECAUSE THERE WERE ONLY A FEW STAPLES REMAINING. THE PRODUCT WAS USED ON THE STOMACH. THE CARTRIDGE COLOR WAS GREEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25363274 ↗MalfunctionJun 2, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING A ROBOTIC PANCREATODUODENECTOMY, THE STOMACH WAS TRANSECTED USING TWO GREEN CARTRIDGE FIRINGS. MALFORMED STAPLES WERE OBSERVED FREQUENTLY ON THE FIRST FIRING. IT WAS DIFFICULT TO DETERMINE WHETHER THERE WERE MALFORMED STAPLES ON THE SECOND FIRING BECAUSE THERE WERE ONLY A FEW STAPLES REMAINING. THE PRODUCT WAS USED ON THE STOMACH. THE CARTRIDGE COLOR WAS GREEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25363273 ↗MalfunctionMay 5, 2026Failure to Fire
IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE, WHEN THE DEVICE WAS FIRED IT DID NOT TAKE THE FULL STAPLE LINE, AND THE UNFIRED STAPLES FELL INTO THE PATIENT WITH SIGNIFICANT AMOUNT MORE THAN NORMAL. NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 25083678 ↗MalfunctionOct 29, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE ROW ALONG THE CUT LINE DID NOT FORM PROPERLY. THE STAPLER WAS USED FOR A TOTAL OF SIX FIRINGS. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417013 ↗
Other Staple, implantable devices
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- Signia SIGPHANDLECovidien LP · STAPLE, IMPLANTABLE1 recall3 deaths5,356 reports
- ECHELON FLEX PSEE60AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- ENDOPATH ATS45Ethicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE2 deaths2,046 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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