PRINCESS 8653224Recalls & reported problems
Richard Wolf GmbH · WORKING ELEMENT PASSIVE MONO/BIPO open, compatible with telescopes Ø 2.7 mm, bayonet-cap, reusable · Class 2
Data updated Oct 16, 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 04055207042908), received between Mar 16, 2023 and Mar 16, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Flare or Flash” (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.
Most reported problems
Device problems
- Flare or Flash1
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.
MalfunctionMar 16, 2023Flare or Flash; Flare or Flash
THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING WORKING ELEMENT PASSIVE MONO/BIPO, PART NO. 8653224 WITH LOT NO. 1506016. ACCORDING TO THE RECEIVED INFORMATION: "DURING THE RESECTION, 10 MINUTES AFTER THE BEGINNING, WE HEARD A THUD: THERE WAS A FLAME AND IT REMAINED INCANDESCENT FOR 1 MINUTE. THE BIPOLAR CABLE CAUGHT FIRE AT THE BASE OF THE CONNECTION (RESECTION HANDLE SIDE)." THE TREATMENT WAS CONTINUED WITH OTHER PRODUCTS AND COMPLETED WITH AN UNSPECIFIED DELAY. THE USER INFORMED RICHARD WOLF GMBH THAT THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16559233 ↗
Other RESECTOSCOPE, WORKING ELEMENT devices
- S-LINE 8680224Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT7 reports
- E-LINE 86553841Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT7 reports
- S-LINE 8680225Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT5 reports
- S-LINE 8680204Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT5 reports
- S-LINE 8680205Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT1 death5 reports
- NA 8654282Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT3 reports
- PRINCESS 8653018Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT2 reports
- SHARK 8674225Richard 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 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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