NA 8654911Recalls & reported problems
Richard Wolf GmbH · LASER WORKING INSERT 12/30 7.5FR round, working channel for instruments up to 7.5Fr, compatible with 24Fr sheaths, and telescopes Ø 4mm, with introduction port, bayonet-cap, 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 04055207018835), received between Oct 28, 2025 and Oct 28, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionOct 28, 2025Break; Break
IT WAS REPORTED THAT DURING A LASER ENUCLEATION OF THE PROSTATE, THE SURGEON MENTIONED THAT THE LASER BRIDGE WAS LOOSE. SHE CONTINUED THE CASE AND APPROXIMATELY 10-15 MINUTES INTO LASERING, THE LASER WORKING CHANNEL BROKE OFF INTO HER HAND. THE STERILE PROCESSING DEPARTMENT (SPD) WAS ABLE TO IMMEDIATE-USE STEAM STERILIZATION (IUSS) WITH ANOTHER DEVICE AND THE CASE RESUMED WITHOUT INCIDENT. ALTHOUGH NO INJURIES WERE REPORTED AND THE PLANNED PROCEDURE COULD BE COMPLETED WITH A BACK-UP DEVICE, THERE WAS A DELAY OF HALF AN HOUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23404871 ↗
Other RESECTOSCOPE devices
- Olympus A22040AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall1,764 reports
- Olympus A42011AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall963 reports
- Olympus A22041AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall656 reports
- Olympus A22042AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall55 reports
- Olmypus WA22017AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall31 reports
- Olympus A22040TOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall23 reports
- Olympus A22041TOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall12 reports
- Olympus A22014AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall11 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.
How reports and recalls are matched · Editorial policy · Report an error on this page