SINGULAR 000991Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653405053262), received between Feb 26, 2016 and May 10, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMay 10, 2016Break

  IT WAS REPORTED BY THE END-USER FACILITY THAT DURING THE USE OF A SINGULAR POLYPECTOMY SNARE, A PIECE OF THE SNARE BROKE OFF IN THE PATIENT'S COLON WHEN THE SNARE WAS OPENED. PER REPORT THE PIECE WAS RETRIEVED AND REMOVED FROM THE PATIENT IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS, SURGICAL DELAY OR PATIENT INJURY. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5644690 ↗
• MalfunctionFeb 26, 2016Component Falling

  IT WAS REPORTED BY THE END-USER FACILITY THAT DURING THE USE OF A SINGULAR POLYPECTOMY SNARE, THE SNARE LOOP FELL OFF OF THE DEVICE AND INTO THE PATIENT'S BOWEL ON ITS SECOND PASS. THE LOOP WAS RETRIEVED AND PER REPORT THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5463812 ↗