PROXIMATE XR30BRecalls & reported problems
Ethicon Endo-Surgery, LLC · Proximate Linear Stapler Reloads · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705036013433), received between Oct 2, 2023 and Oct 2, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (2 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.
Reports received per month
Most reported problems
Device problems
- Failure to Fire2
- Failure to Form Staple2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER LINE WAS UNEVEN AND THE STAPLE B-SHAPE WAS NOT COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17853234 ↗MalfunctionOct 2, 2023Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER LINE WAS UNEVEN AND THE STAPLE B-SHAPE WAS NOT COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17853215 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.