SHARK 46782201Recalls & reported problems
Richard Wolf GmbH · COAG ELECTRODE MONO 22-24FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24/26 Fr, electrode shape: roller, fork color green, stem color transparent, PACK = 5 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 04055207049006), received between Jul 17, 2020 and Jul 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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
- Device Damaged by Another Device1
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.
MalfunctionJul 17, 2020Device Damaged by Another Device; Device Damaged by Another Device
ON (B)(6) 2020, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): DURING PROCEDURE THE ELECTRODE BURNED THE SCOPE. THE DEVICE WAS USED ON THE PATIENT WHEN THE REPORTED ISSUE OCCURED BUT THERE WAS NO INJURY OR ILLNES TO THE PATIENT OR PERSONNEL DUE TO THIS ISSUE. HOWEVER, THE REPORTED ISSUE CAUSED A DELAY IN THE PROCEDURE BUT THE DELAY DID NOT PUT THE PATIENT AT RISK. A SIMILAR BACK-UP DEVICE WAS AVAILABLE AND THE SCHEDULED PROCEDURE WAS COMPLETED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10288869 ↗
Other ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL devices
- M3 Gold M3-30AGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall11 reports
- USA Elite MLE-24-012Gyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall9 reports
- Olympus WA22603SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall7 reports
- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22332DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.