SINGULAR 000959Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10653405053187), received between Aug 24, 2016 and Sep 7, 2016 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2016Component Falling

  THE END USER FACILITY REPORTED THAT DURING USE OF A SINGULAR POLYPECTOMY SNARE IN A COLONOSCOPY PROCEDURE ON (B)(6) 2016 AND WHILE ATTEMPTING TO RESECT A POLYP, THE SNARE LOOP FELL OFF THE END OF THE CATHETER CABLE. THE SNARE LOOP WAS RETRIEVED FROM THE PATIENT COLON WITH NO PROBLEMS REPORTED. THE COLONOSCOPY WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY. THIS REPORT IS RAISED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5933184 ↗
• MalfunctionSep 1, 2016Break

  AS REPORTED ON MW 5063523 THE FACILITY STATED DURING A COLONOSCOPY ON (B)(6) 2016, ATTEMPTED TO DO A POLYPECTOMY USING A 000959 SINGULAR POLYPECTOMY SNARE. WHILE THE DEVICE WAS BEING DEPLOYED THE SNARE PORTION OF THE DEVICE BROKE OFF INTO THE PATIENT. THE DEVICE WAS RETRIEVED FROM THE PATIENT USING BIOPSY FORCEPS. NO INJURY TO THE PATIENT HAS BEEN REPORTED. TO DATE THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION OF LONG TERM ADVERSE EFFECT HAS OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5921297 ↗
• MalfunctionAug 24, 2016Detachment Of Device Component

  THE USER FACILITY REPORTED THAT DURING THE MANEUVER OF DIATHERMOCOAGULATION, THE LOOP OF THE SINGULAR POLYPECTOMY SNARE WAS DETACHED FROM THE CUTTING WIRE AND WAS SAFELY RETRIEVED WITH FORCEPS. THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS, NO SURGICAL DELAY OR PATIENT INJURY REPORTED. DESPITE THE ATTEMPT TO OBTAIN ADDITIONAL PATIENT/EVENT INFORMATION, TO DATE NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT DEMOGRAPHIC INFORMATION OR THE REPORTED INCIDENT. THIS REPORT IS RAISED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5900881 ↗