PANOVIEW 8964401Recalls & reported problems
Richard Wolf GmbH · NEPHROSCOPE 12° 20.8FR WL 224MM rigid, with parallel ocular lens, working channel for instruments up to 10.5 Fr, TL 387 mm, rod lens system · Class 2
- 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 04055207023266), received between Sep 17, 2020 and Feb 27, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Optical Distortion” (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
- Optical Distortion1
- Optical Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2024Optical Problem; Optical Problem
A USER FACILITY HAS INFORMED (B)(6) OF AN ISSUE REGARDING A NEPHROSCOPE 12° 20.8FR WL 224MM, PART ID: 8964.401, SN (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THERE WAS INSUFFICIENT LIGHT TRANSMISSION DURING THE OPERATION (PERCUTANEOUS NEPHROLITHOLAPAXY). THE SCHEDULED PROCEDURE WAS COMPLETED. HOWEVER, THE OPERATION TIME WAS EXTENDED BY 30 MINUTES TO CHANGE TO A REPLACEMENT DEVICE. THE DEVICE HAD TO BE REPLACED INTRAOPERATIVELY. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18789966 ↗InjurySep 17, 2020Optical Distortion; Optical Distortion
IT WAS REPORTED TO RICHARD WOLF THAT AT 15:00 P.M. ON (B)(6) 2020, THE PATIENT UNDERWENT PERCUTANEOUS NEPHROLITHOTOMY AND URETEROSCOPIC BILATERAL URETERAL STENT PLACEMENT UNDER GENERAL ANESTHESIA. AFTER THE OPERATION OF BILATERAL URETERAL STENT PLACEMENT UNDER URETEROSCOPE, THE DOCTOR FOUND THAT THE NEPHROSCOPE COULD NOT COMPLETE THE WHITE BALANCE, THE NEPHROSCOPE WAS BLURRED AND COULD NOT BE USED NORMALLY WHEN PREPARING THE PERCUTANEOUS NEPHROSCOPE INSTRUMENTS AT 16:20. THE NURSE IMMEDIATELY INFORMED THE MEDICAL DEVICE DEPARTMENT FOR MAINTENANCE AND EMERGENCY DEPLOYMENT. THE DEVICE DEPARTMENT IMMEDIATELY DEPLOYED A NEPHROSCOPE AT 17:45, THE OPERATION CONTINUED, AND THE PATIENT RETURNED TO THE WARD AT ABOUT 18:20. THIS LED TO A PROLONGED OPERATION TIME AND THE RISK OF INTRAOPERATIVE HEMORRHAGE. THE OPERATION WAS PERFORMED BY EMERGENCY DEPLOYMENT OF NEPHROSCOPE OUTSIDE THE HOSPITAL. THIS INCREASED THE RISK OF INTRAOPERATIVE INFECTION.
Patient problems: Insufficient Information
MAUDE report 10549723 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.