NA AG-5336-241023Recalls & reported problems
Hangzhou AGS MedTech Co., Ltd. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06959664902165), received between Jul 29, 2026 and Jul 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Detachment of Device or Device Component
No adverse event related to this incident. It was reported to (b)(6) that a cold only snare completely broke off inside of a patient while trying to cut a polyp. The whole loop fell off when the snare was closed. The wire piece was retrieved and no patient injury was noted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065887 ↗
Other Snare, Non-Electrical devices
- Captivator™ COLD M00561100Boston Scientific Corporation · SNARE, NON-ELECTRICAL377 reports
- CAPTIVATOR II M00561220Boston Scientific Corporation · SNARE, NON-ELECTRICAL1 recall150 reports
- Single Use Electrosurgical Snare SD-400 SD-400U-10Olympus Medical Systems Corp. · SNARE, NON-ELECTRICAL1 recall13 reports
- Single Use Electrosurgical Snare SD-400 SD-400U-15Olympus Medical Systems Corp. · SNARE, NON-ELECTRICAL1 recall7 reports
- M-Catch 1175-01Diversatek Healthcare, Inc. · Snare, Non-Electrical1 recall0 reports
- Exacto 00711115US Endoscopy · SNARE, NON-ELECTRICAL35 reports
- CAPTIVATOR II M00561240Boston Scientific Corporation · SNARE, NON-ELECTRICAL26 reports
- Single Use Electrosurgical Snare SD-400 SD-400-10Olympus Medical Systems Corp. · SNARE, NON-ELECTRICAL16 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.