RIWO-ART 8921014Recalls & reported problems
Richard Wolf GmbH · TROCAR SLEEVE STRAI. CAP 5.5MM WL 100MM stainless steel-sheath tube smooth, distal tip straight, with Magnet-ball valve, with insufflation valve, reusable · Class 2
Data updated Oct 18, 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 04055207022115), received between Sep 23, 2026 and Sep 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation1
- Poor Quality Image1
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.
MalfunctionSep 23, 2026Poor Quality Image; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873356 ↗
Other Trocar, gastro-urology devices
- Busse Hospital Diposables B1352Robert Busse & CO., Inc. · Trocar, Gastro-Urology2 recalls0 reports
- Busse Hospital Disposables B1354Robert Busse & CO., Inc. · Trocar, Gastro-Urology2 recalls0 reports
- Busse Hosptial Disposables B1654Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B1568Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B1144Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B7345Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B1570Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital DIsposables B1351Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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