MIDI-SIZE 86770155Recalls & reported problems
Richard Wolf GmbH · SHEATH RESECTOSCOPE 14.5FR color code white, SL 221 mm, oval, slanted distal end, compatible with working element 8677.224, and telescopes Ø 2.7 mm, 0°, with irrigation stopcock, quick-lock, reusable · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207028230), received between Sep 7, 2018 and May 19, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Break
IT WAS REPORTED THAT THE CERAMIC TIP CAME OFF INSIDE OF THE PATIENT DURING THE PROCEDURE. THE SURGERY WAS PROLONGED BY AN HOUR RETRIEVING THE FALLEN PIECE. DUE TO IT, THE PATIENT REQUIRED ADDITIONAL ANESTHESIA. THERE WAS NO REPORT OF INJURY TO THE PATIENT, AND THE PLANNED PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25220647 ↗MalfunctionSep 7, 2018Break; Material Fragmentation; Material Fragmentation
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, HEREINAFTER REFERRED TO AS RWMIC WAS NOTIFIED OF AN EVENT THAT OCCURRED DURING PATIENT USE AT THE USER FACILITY. DATE OF OCCURRENCE WAS NOT SPECIFIED. THE CUSTOMER REPORTED THAT SHAVINGS FROM THE INNER SHEATH OF THE CERAMIC TIP FLAKED OFF INSIDE A PATIENT'S BLADDER. THE PIECES WERE REMOVED FROM THE PATIENT AND THERE WAS NO ADVERSE OUTCOME TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7855453 ↗
Other RESECTOSCOPE, WORKING ELEMENT devices
- E-LINE 86553841Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT7 reports
- S-LINE 8680224Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT7 reports
- S-LINE 8680225Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT5 reports
- S-LINE 8680205Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT1 death5 reports
- S-LINE 8680204Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT5 reports
- NA 8654282Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT3 reports
- SHARK 8674225Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT2 reports
- PRINCESS 8653018Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT2 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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