SHARK 46782225Recalls & reported problems
Richard Wolf GmbH · CUTTING ELECTRODE MONO 22FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, continuous irrigation, 22/24 Fr, loop: round, wire Ø 0.25 mm, fork color green, stem color transparent, PACK = 10 PCS, for Shark Resectoscope, sterile, for single use · 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 04055207049020), received between Aug 14, 2020 and Aug 14, 2020 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2020Material Separation; Material Separation
IT WAS REPORTED BY THE USER FACILITY ((B)(6) 2020) THAT WHILE RESECTING TISSUE THE FIRST LOOP BROKE, AND THE SAME WHILE USING THE SECOND BUT THE LOOP BROKE COMPLETELY OFF INTO THE PATIENT. WILL THE DEVICE BE RETURNED? NO. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10408298 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.