NA 7990001Recalls & reported problems
Richard Wolf GmbH · CLEANING BRUSH Ø 2MM TL 1200MM for flexible endoscopes, with channel Ø 1,0-1,50mm, brush length 20mm, PACK=10 PCS, color yellow, for single use · Class 1
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 04055207000649), received between Jan 16, 2024 and Jan 16, 2024 — classified as 1 malfunction.
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.
MalfunctionJan 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A USER FACILITY HAS INFORMED (B)(6) OF AN ISSUE REGARDING A CLEANING BRUSH Ø 2MM TL 1200MM, PART ID: 7990001, LOT # 44396. ACCORDING TO THE RECEIVED INFORMATION, DURING A SURGICAL PROCEDURE THE DOCTOR FOUND A CLEANING BRUSH BLOCKING THE WORKING CHANNEL OF AN INSTRUMENT 7355076, FLEXIBLE SENSOR-URETERORENOSCOPE BOA VISION. THE BRUSH HAD CERTAINLY BECOME DETACHED FROM THE SINGLE-USE BRUSH. THE DETACHED BRUSH COULD BE ISOLATED. THERE WAS ONLY A MINIMAL TIME DELAY AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. HOWEVER, AS THE REMAINING CLEANING BRUSH IN AN INSTRUMENT CAN LEAD TO A POTENTIAL HARM TO THE PATIENT, WE CONSIDER THIS CASE AS REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18522022 ↗
Other ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE devices
- Hedgehog SBD-289Boston Scientific Corporation · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE129 reports
- Channel cleaning brush BW-20TOlympus Medical Systems Corp. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE90 reports
- MEDLINE DYK500FSAWMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- VERIFY LCC101Steris Corporation · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK500FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MetriSPONGE 10-4025Metrex Research, LLC · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK215FSMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 recall0 reports
- MEDLINE DYK1000TSEMedline Industries, Inc. · ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE1 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 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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