NA 7305001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04055207013656), received between Feb 7, 2017 and Sep 22, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Contamination

  Patient problems: Urinary Tract Infection

  MAUDE report 50857504 ↗
• InjuryMar 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A MEDICAL SUPPLIER AND RICHARD WOLF GMBH (RWGMBH) HAS BEEN INFORMED OF AN ISSUE REGARDING AN FIBER-CYSTOSCOPE 15FR WL 400MM, PART ID: 7305.001, SN# (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THE GENERAL HOSPITAL OF NIKAIA IN ATHENS REPORTED THREE SERIOUS INCIDENTS WITH PATIENTS DEVELOPING A SEVERE HYPOXEMIA, 10-15 MINUTES FOLLOWING CYSTOSCOPY. ONE OF THE PATIENT HAD TO BE TRANSFERRED TO THE INTENSIVE CARE UNIT. THESE HAPPENED ON (B)(6) JAN, (B)(6) FEB, AND (B)(6) 2024 RESPECTIVELY. THE CASES WERE STARTED AFTER THE USE OF THE INSTRUMENT. ALL PATIENTS ARE NOW DOING WELL.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18935553 ↗
• InjuryMar 5, 2024Poor Quality Image; Poor Quality Image

  A USER HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING AN FIBER-CYSTOSCOPE 15FR WL 400MM, PART ID: 7305.001, SN# (B)(6). ACCORDING TO THE RECEIVED INFORMATION, DURING THE PATIENT'S TREATMENT, VISION BECAME INCREASINGLY POOR AS WATER/CONDENSATION ON THE LENS CAUSED IT TO FOG UP. LATER, THE USER STATED THAT THE TREATMENT HAD TO BE DISCONTINUED DUE TO THIS. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836687 ↗
• MalfunctionJan 12, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF ALL 2016-2017 COMPLAINT FILES THAT RW MIC IS CONDUCTING. THE COMPLAINT SPECIALIST DETERMINED A RE-ASSESSMENT OF THE MDR DECISION FOR THIS COMPLAINT WAS NEEDED AND THAT, THIS COMPLAINT DUE TO A IF A SIMILAR FAILURE OR MALFUNCTION WERE TO OCCUR WITH THE SAME OR SIMILAR DEVICE, COULD DEATH, LIFE THREATENING INJURY OR LIFE-THREATENING ILLNESS OCCUR?" PREVIOUSLY IN 2017, THE COMPLAINT SPECIALIST AT THAT TIME, DETERMINED AN MDR WAS NOT NEEDED DUE TO "NO INJURY TO PATIENT OR STAFF. BACKUP DEVICE READILY AVAILABLE FOR USE. MINIMAL DELAY, MINIMAL RISK TO PATIENT. PROCEDURE COMPLETED AS SCHEDULED." FACTS OF THE CASE AS REPORTED TO RICHARD WOLF BY THE USER FACILITY: "THERE WAS SMALL BLACK SPECKLES IN THE PATIENT. THEY BELIEVE IT IS PART OF THE INSULATION FROM THE SCOPE." ADDITIONAL DETAILS: WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. THE SPECKLES THAT WERE SENT IN WITH THE SCOPE DID NOT COME FROM A PATIENT'S BLADDER. WE FLUSHED THE SCOPE WITH WATER A SYRINGE AND THESE SPECKLES BECAME PRESENT IN THE SPECIMENT CUP. WE SEALED THE CUP WITH A LID AND PUT IN BIOHAZARD BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235925 ↗
• MalfunctionDec 13, 2021Flaked; Flaked

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT: RESULTS OF THE DEVICE EVALUATION/INVESTIGATION; ADDITIONAL DETAILS RECEIVED FROM THE USER FACILITY. ONE OTHER STATEMENT PROVIDED BY THE USER FACILITY: "I SPOKE TO THE DOCTOR, SHE SAID THE PT WAS FEMALE AND CANNOT REMEMBER HER DOB. SHE DOESN'T BELIEVE THERE WAS A RISK TO THE PT BUT CAN'T SAY FOR SURE BECAUSE WE ARE UNAWARE OF WHAT THE MATERIAL BEING FLUSHED THROUGH WAS. DEVICE INVESTIGATION: THE DEVICE WAS EVALUATED USING VISUAL AND FUNCTIONAL MEANS. THE REPORTED CONDITION "BLACK FLUID DRIPPING OUT OF SCOPE/METAL LIKE SHAVINGS IN THE BLADDER" WAS CONFIRMED. FINDINGS: WORKING CHANNEL LEAKS FROM TIP, MOISTURE IN OPTIC SYSTEM. THERE IS NO EVIDENCE OF METAL SHEDDING, NO PARTICLES NOR FOREIGN MATTERS INSIDE WORKING CHANNEL. DEFLECTION STIFFNESS IS VERY LIKELY CAUSED BY THE MOISTURE IN OPTIC SYSTEM. LEAKAGE OF WORKING CHANNEL RESULTED IN GRAPHITE SPILL THAT LOOKED LIKE A BLACK FLUID. GRAPHITE POWDER IS USED AT THE VERTEBRA TO LUBRICATE THE DEFLECTION AND MOVE IT SMOOTHER AND AS WELL WHEN THE SHAFT IS MANUFACTURED FOR LUBRICATING ALL ITS COMPONENTS (PICTURE BUNDLE, WORKING CHANNEL AND ILLUMINATION FIBER LIGHTS). DAMAGE OCCURRED EITHER DURING REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983803 ↗
• MalfunctionFeb 7, 2017Device Issue; Device Issue

  FOLLOW UP #1

  Patient problems: Foreign Body In Patient

  MAUDE report 6308281 ↗