Skimmer® 1883523Recalls & reported problems
Medtronic Xomed, Inc. · BLADE 1883523 SKIMMER 3PK 3.5MM 22.5CM · Class 1
All models of Skimmer (7)
Data updated Oct 16, 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 20681490047399), received between Apr 11, 2022 and Apr 11, 2022 — classified as 1 malfunction.
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
Device problems
- Break1
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.
MalfunctionApr 11, 2022Break; Break
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE INNER LUMEN OF THE BLADE BROKE. THE DEBRIDER STOPPED OSCILLATING SO THE STRAIGHT SHOT WAS REMOVED FROM THE PATIENT TO SEE IF THE BLADE NEEDED TO BE CLEANED. WHEN THEY TRIED TO REMOVE THE BLADE, THE SCRUB NOTICED THAT THE INNER LUMEN BLADE WAS SEPARATED FROM THE OUTER LUMEN. SHE TRIED TO FORCE IT BACK TOGETHER BY PUSHING ON IT. THEY DO NOT KNOW IF THE INNER BLADE BROKE WHILE IN USE OR AFTER IT WAS REMOVED FROM THE PATIENT AND THEY WERE TRYING TO CLEAN IT. THE EVENT OCCURRED DURING A MICRO DIRECT LARYNGOSCOPY PROCEDURE WITH BIOPSY. THE PRODUCT HAD CONTACT WITH A PATIENT WITH (B)(6). THERE WAS NO PATIENT IMPACT. THERE WAS A DELAY OF 45 MINUTES IN THE SURGICAL PROCEDURE. NO BROKEN PIECES OF THE REPORTED PRODUCT REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCTS. ON FOLLOW-UP, IT WAS REPORTED THAT THEY STOPPED DEBRIDING AS THE BLADE WAS NOT OPENING/CLOSING PROPERLY OR THE MOUTH OF THE BLADE WAS NOT IN CORRECT POSITION. STAFF TRIED TO UNCLOG THE BLADE BUT COULD NOT OPEN THE MOUTH OF THE BLADE, TRIED REMOVING THE BLADE WHILE THE SUCTION WAS STILL ATTACHED. REMOVED BLADE TO UNCLOG FROM BOTH ENDS OF BLADE. T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14078422 ↗
Other BUR, EAR, NOSE AND THROAT devices
- Quadcut® 1884380HRMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall7 reports
- Silver Bullet® 1882905HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall3 reports
- Diego Elite MBUR6060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall2 reports
- Quadcut® 1884380HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- RAD® 1882916Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- N/A 1884032Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- DIEGO ELITE MBUR5060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884033HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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