SINGULAR 000985Recalls & reported problems
Conmed Corporation · CONMED SINGULAR Polypectomy Snare; Small Oval Loop, Soft Wire, Olympus Connector, 230 cm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405053323), received between Mar 10, 2017 and Mar 10, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
Device problems
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2017Detachment Of Device Component; Detachment Of Device Component
AS REPORTED BY USER FACILITY, ON (B)(6) 2017, DURING A COLONOSCOPY, THE SURGEON DEPLOYED THE SNARE AND THE WIRE CAME OUT OF THE CATHETER COMPLETELY UPON THE FIRST PASS AND FELL INTO THE PATIENT. THE ENTIRE WIRE CAME OUT, LEAVING NOTHING ATTACHED TO THE CATHETER. IT WAS PROMPTLY RETRIEVED BY THE DOCTOR AND REMOVED. THERE WAS NO SURGICAL DELAY OR PATIENT INJURY. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6394867 ↗
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- Single Use 3-Lumen Sphincterotome V KD-V411M-0725Olympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)160 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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