E-LINE 8702534Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207020036), received between Nov 22, 2019 and Oct 12, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2023Poor Quality Image; Poor Quality Image

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A URETERORENOSCOPE 5° 6/7.5FR WL 430MM, PART ID: 8702534, SERIAL NUMBER # (B)(6). SURGERY PLANNED ON AUGUST 5, 2023, RESOLUTION OF PATIENT CASE WITH URETERAL LITHIASIS, URETERAL LITHOTRIPSY SURGERY IS PLANNED USING RICHARD WOLF URETERORENOSCOPE 5° 6/7.5FR. ACCORDING TO THE INITIAL REPORTER, THE PROCEDURE BEGINS, PERCEIVING POOR IMAGE QUALITY AT THE BEGINNING OF THE PROCEDURE, WITH THE PRESENCE OF AN EXTERNAL HALO THAT REDUCES THE FIELD OF VISION, MAKING MANEUVERS WITHIN THE URETER DIFFICULT. AN ATTEMPT IS MADE TO PERFORM LITHOTRIPSY WITH A PNEUMATIC LITHOTRIPTER; DUE TO VISION DIFFICULTIES, IT IS DECIDED TO SUSPEND PROCEDURE AND RESCHEDULE THE CASE UNTIL A NEW WORK ITEM IS AVAILABLE, EXPOSING THE PATIENT AGAIN TO ANOTHER ANESTHETIC EVENT AND ANOTHER HOSPITALIZATION. THERE WAS A TIME DELAY ABOUT 90 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 17920799 ↗
• MalfunctionApr 10, 2020No Display/Image; No Display/Image

  FOLLOW UP REPORT TO PROVIDE ADDITIONAL INFORMATION TO FDA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9951015 ↗
• MalfunctionNov 22, 2019Poor Quality Image; Poor Quality Image

  ON (B)(6) 2019, (B)(4) RECEIVED THE FOLLOWING INFORMATION: DURING THE OPERATION, THE DOCTOR SUDDENLY FOUND THAT THE VISION OF THE URETEROSCOPE WAS BLURRED. THEY WERE UNABLE TO PERFORM THE OPERATION AND COULD NOT SEE CLEARLY AT ALL. THE OPERATING ROOM WAS IMMEDIATELY INFORMED TO PREPARE THE SPARE URETEROSCOPE FOR SUBSEQUENT OPERATION. NO DISCOMFORT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365034 ↗