Snare Wire MAJ-218Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170035739), received between Oct 26, 2022 and Nov 30, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Device Handling Problem1
- Failure to Clean Adequately1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2022Device Contamination with Chemical or Other Material; Failure to Clean Adequately; Device Contamination with Chemical or Other Material; Failure to Clean Adequately
AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, AFTER BEING AC (AUTOCLAVE) STERILIZED THE SNARE WIRE EXPERIENCED FREQUENT CASES OF FIBROUS MATTER ADHERING TO THE TIP OF THE WIRE. THE EVENT OCCURRED DURING REPROCESSING OF SUBJECT DEVICE. THERE IS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15888204 ↗MalfunctionOct 26, 2022Device Handling Problem; Device Handling Problem
AS REPORTED FOR THIS DEVICE BY THE CUSTOMER, THE DEVICE WAS NEW AND USED FOR SET UP WITHOUT STERILIZATION AS REQUIRED FOR A NEW DEVICE PRIOR TO BEING USED. THERE IS NO PATIENT INVOLVEMENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE, SINCE THE DEVICE HAD AN ISSUE OF NOT BEING ABLE TO BE INSERTED IN THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15677140 ↗
Other SNARE, FLEXIBLE devices
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- SENSATION Short Throw M00562670Boston Scientific Corporation · SNARE, FLEXIBLE1 recall178 reports
- SENSATION Short Throw M00562650Boston Scientific Corporation · SNARE, FLEXIBLE1 recall173 reports
- Ultratome XL M00535900Boston Scientific Corporation · SNARE, FLEXIBLE205 reports
- CAPTIVATOR M00562340Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls71 reports
- CAPTIVATOR II M00561230Boston Scientific Corporation · SNARE, FLEXIBLE1 recall83 reports
- CAPTIVATOR M00562320Boston Scientific Corporation · SNARE, FLEXIBLE2 recalls32 reports
- CAPTIVATOR M00562300Boston Scientific Corporation · SNARE, FLEXIBLE1 recall78 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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