ETHICON ER60TRecalls & reported problems
Ethicon Endo-Surgery, LLC · ETHICON 3D RELOAD 60MM BLACK · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705036040828), received between Jun 29, 2026 and Jun 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Form Staple” (1 report).
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 Staple1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING IN AN RPG CASE, THE STAPLE LINE REINFORCEMENT WAS USED FOR ESOPHAGEAL TRANSECTION. A STAPLE MALFORMATION AREA WAS FOUND AROUND THE MIDDLE OF THE STAPLE LINE. ACCORDING TO THE HOSPITAL, WHEN THEY WERE GOING TO REMOVE THE STAPLE MALFORMATION AREA, THE REMAINING STAPLE LINE WAS PROPERLY FORMED. THEREFORE, THERE WAS NO ISSUE, BUT THE SALES REP CONCERNS ABOUT THE MALFORMATION ISSUE. THE CARTRIDGE COLOR WAS BLACK. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25651848 ↗
Other Staple, implantable devices
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- 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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