ENDOBUTTON 7210081Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010496973), received between Sep 8, 2017 and Dec 18, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING SURGERY, A DELAY OF LESS THAN 30 MINUTES WAS CAUSED BECAUSE A FOREIGN SUBSTANCE (LIKE A HAIR) WAS FOUND INSIDE THE STERILE PACKAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8176777 ↗
• MalfunctionSep 8, 2017Incomplete or Missing Packaging

  IT WAS REPORTED THAT WHEN THE BOX WAS OPENED, THERE WAS NO IMPLANT INSIDE AND NO STICKER LABEL EITHER. THE ONLY THING INSIDE THE BOX WAS THE PRODUCT BROCHURE. THE SURGEON DECIDES TO USE ANOTHER COMPANY'S PRODUCTS INSTEAD. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6851239 ↗