EndoVive One Step Button M00563040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729268833), received between Apr 2, 2018 and Apr 2, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

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.

• MalfunctionApr 2, 2018Detachment Of Device Component; Detachment Of Device Component

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-00992 FOR THE FIRST ENDOVIVE¿ ONE STEP BUTTON¿ 3005099803-2018-00993 FOR THE SECOND ENDOVIVE¿ ONE STEP BUTTON¿. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON WAS USED DURING A PEG REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TRIED TO GRASP THE PEG TUBE FROM THE STOMACH TO PULL IT THROUGH BUT THE TUBE KEPT BREAKING. A SECOND ONE STEP BUTTON GASTROSTOMY KIT WAS USED; HOWEVER, IT HAPPENED AGAIN. REPORTEDLY, ALLIGATOR FORCEPS WERE USED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7389452 ↗
• MalfunctionApr 2, 2018Detachment Of Device Component; Detachment Of Device Component

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2018-00992 FOR THE FIRST ENDOVIVE¿ ONE STEP BUTTON¿ 3005099803-2018-00993 FOR THE SECOND ENDOVIVE¿ ONE STEP BUTTON¿. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE ONE STEP BUTTON WAS USED DURING A PEG REPLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN TRIED TO GRASP THE PEG TUBE FROM THE STOMACH TO PULL IT THROUGH BUT THE TUBE KEPT BREAKING. A SECOND ONE STEP BUTTON GASTROSTOMY KIT WAS USED; HOWEVER, IT HAPPENED AGAIN. REPORTEDLY, ALLIGATOR FORCEPS WERE USED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7389441 ↗