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RESECTION MASTER 8659071Recalls & reported problems

Richard Wolf GmbH · OUTER SHEATH RESECTOSCOPE 27FR color code yellow, WL 184mm, round, distal end straight, compatible with outer sheath 8659071 for Resection Master Resectoscope 27Fr with integrated chip suction, and telescopes Ø 3.3mm, 30°, with Luer connection, E-Line quick connection, reusable · Class 2

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 04055207019078), received between Mar 23, 2018 and Mar 23, 2018 — 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

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • MalfunctionMar 23, 2018Material Fragmentation; Material Fragmentation

    RICHARD WOLF (B)(4) ((B)(4)) WAS NOTIFIED BY USER FACILITY THAT DURING A PROCEDURE THE TIP OF THE SHEATH BROKE INTO PIECES AND FELL INTO THE PATIENT. PIECES WERE RECOVERED FROM PATIENT. FACILITY ALSO REPORTED BURN MARKS ON THE WORKING ELEMENT AND DAMAGED ELECTRODE. AT THIS TIME, THE WORKING ELEMENT AND SHEATH ARE SUSPECT DEVICES AND A REPORT WILL BE SUBMITTED FOR EACH DEVICE. 1) WORKING ELEMENT (ID #(B)(4)) (MDR 9611102-2018-00007); 2) OUTER SHEATH (ID #(B)(4)) (MDR 9611102-2018-00006). SHEATH MANUFACTURED ON 18OCT2017 WITH A BATCH SIZE OF (B)(4) UNITS. SHEATH WAS PURCHASED BY FACILITY ON (B)(4) 2017.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 7367694 ↗

Other RESECTOSCOPE devices

All RESECTOSCOPE devices →

Sources and updates

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