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NA 8309072Recalls & reported problems

Richard Wolf GmbH · TROCAR SLEEVE CAP 2.2MM WL 60MM plastic-sheath tube with thread, distal tip straight, with rubber cap, without insufflation stopcock, reusable · Class 2

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 04055207014844), received between Oct 17, 2022 and Oct 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 17, 2022Material Fragmentation; Material Fragmentation

    RWGMBH REFERENCE COMPLAINT NO. (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION: (SEE H10).

    Patient problems: Foreign Body In Patient

    MAUDE report 15620552 ↗

Other Trocar, gastro-urology devices

All Trocar, gastro-urology devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.