NA 8905331Recalls & reported problems
Richard Wolf GmbH · TROCAR SLEEVE STRAI. CAP 5.8MM WL 62MM flexible plastic sheath with thread, distal tip straight, with membrane valve, reusable · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207021743), received between Apr 4, 2025 and Apr 4, 2025 — classified as 1 death.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- Pulmonary Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 4, 2025Material Separation; Material Separation
ACCORDING TO THE INFORMATION RECEIVED, DURING THE THORACOSCOPY PROCEDURE, SURGEON INITIALLY INSERTED THE TROCAR THROUGH WHICH THE SCOPE WAS PASSED TO VISUALIZE THE PLEURAL SPACE. UNFORTUNATELY, THE VISUALIZATION WAS POOR, AND THE USER DECIDED TO REMOVE THE SCOPE FOR FURTHER ASSESSMENT. HOWEVER, ONCE THE SCOPE WAS REMOVED, THE SURGEON DISCOVERED THAT ONLY THE METALLIC HEAD OF THE TROCAR REMAINED IN THE CHEST, WITH THE PLASTIC CANNULA COMPLETELY MISSING. A SUBSEQUENT CT SCAN OF THE CHEST REVEALED THAT THE MISSING PART OF THE TROCAR WAS LODGED IN THE POSTERIOR PLEURAL CAVITY. AS A RESULT, THE PATIENT WAS TAKEN FOR THORACOTOMY TO REMOVE THE BROKEN PIECE FROM THE POSTERIOR PLEURAL CAVITY. UNFORTUNATELY, FOLLOWING THE SURGERY, THE PATIENT DEVELOPED PULMONARY EDEMA, WAS INTUBATED, AND TRAGICALLY PASSED AWAY ONE DAY AFTER THE OPERATION.
Patient problems: Pulmonary Edema
MAUDE report 21773078 ↗
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 Hospital Disposables B9176R1Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hosptial Disposables B1654Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B7345Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B1559Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposables B8128R1Robert Busse & CO., Inc. · Trocar, Gastro-Urology1 recall0 reports
- Busse Hospital Disposable B1362Robert 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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