n.a. 41335DWRecalls & reported problems
Karl Storz GmbH & Co. KG · Sinus Burr 35k, sterile, 5x · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551409909), received between Dec 5, 2025 and Dec 5, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “No Display/Image” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- No Display/Image2
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.
InjuryDec 5, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT SHAVER BURR DIDN'T FIT WELL INTO SHAVER HANDPIECES. DRILLCUT HANDPIECE STOPPED WORKING DURING SURGICAL PROCEDURE. SURGICAL PROCEDURE (DRAF TYPE III FRONTAL SINUS) HAD TO BE COMPLETED WITHOUT BURR BY USING PUNCHES WHICH DELAYED THE PROCEDURE. BURR HAD TO BE INSERTED WITH FORCE. PROCEDURE HAD TO BE COMPLETED WITHOUT BURR. THIS CAUSED A SURGICAL DELAY OF 112 MINUTES. THREE OTHER PLANNED PROCEDURES WITHIN THE NEXT 4 WEEKS HAD TO BE CANCELLED/RESCHEDULED DUE TO UNAVAILABILITY OF 40° SHAVER BURRS THAT FIT INTO HANDPIECE AND BROKEN HANDPIECE. SINCE THE PROCEDURE HAD TO BE RESCHEDULED, THIS CASE IS REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23729575 ↗InjuryDec 5, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT SHAVER BURR DIDN'T FIT WELL INTO SHAVER HANDPIECES. DRILLCUT HANDPIECE STOPPED WORKING DURING SURGICAL PROCEDURE. SURGICAL PROCEDURE (DRAF TYPE III FRONTAL SINUS) HAD TO BE COMPLETED WITHOUT BURR BY USING PUNCHES WHICH DELAYED THE PROCEDURE. BURR HAD TO BE INSERTED WITH FORCE. PROCEDURE HAD TO BE COMPLETED WITHOUT BURR. THIS CAUSED A SURGICAL DELAY OF 112 MINUTES. THREE OTHER PLANNED PROCEDURES WITHIN THE NEXT 4 WEEKS HAD TO BE CANCELLED/RESCHEDULED DUE TO UNAVAILABILITY OF 40° SHAVER BURRS THAT FIT INTO HANDPIECE AND BROKEN HANDPIECE. SINCE THE PROCEDURE HAD TO BE RESCHEDULED, THIS CASE IS REPORTABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23729547 ↗
Other BUR, EAR, NOSE AND THROAT devices
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- 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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