E-LINE 8703534Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207020104), received between May 28, 2020 and Oct 17, 2023 — classified as 4 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Poor Quality Image; Poor Quality Image

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A URETERORENOSCOPE 12° 8/9.8FR WL 430MM, PART ID: (B)(6), SERIAL NUMBER # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, URS UNDER POOR, CLOUDY VISION. OPERATION WAS TERMINATED EARLY. STONE COULD NOT BE RECOVERED.

  Patient problems: Insufficient Information

  MAUDE report 17950205 ↗
• MalfunctionJul 29, 2020Break

  IT WAS REPORTED THAT A (B)(6) YEAR OLD PATIENT WAS ADMITTED TO THE HOSPITAL AT 9:25 AM ON (B)(6) 2020 FOR "KIDNEY STONES", AND UNDERWENT NEPHROSCOPE SURGERY AT 10:00 AM ON (B)(6). DURING THE OPERATION, THE FIBER URETERAL NEPHROSCOPE WAS BROKEN AND IMMEDIATELY STOPPED USING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10338886 ↗
• MalfunctionJun 26, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE 1ST APPLICATION IN THE URETER, THE DEVICE KINKED (OVER GUIDE WIRE, MOVE TO THE URETERAL CENTER, THEN WITH GENTLE ANGULATION AFTER NEUTRAL KINKING OF THE URETEROSCOPE) THE APPLICATION COULD NOT BE TERMINATED, BECAUSE KINKED DEVICE COULD NO LONGER BE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201175 ↗
• MalfunctionMay 28, 2020Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2019, RICHARD WOLF (B)(4) (RW (B)(4)) RECEIVED THE FOLLOWING INFORMATION: THE INSTRUMENT WAS BENT TOWARDS THE DISTAL END WHILE BEING USED ON A PATIENT. UPON FOLLOW UP WITH THE USER FACILITY, THE FOLLOWING INFORMATION WAS PROVIDED: "ENTERING WITH THE SEMIRIGID URS, TROUBLE-FREE OSTIUM INTUBATION. A NARROWNESS OVER A DISTANCE OF ABOUT 5 CM AT THE HEIGHT OF THE VASCULAR JUNCTION COULD BE SEEN, BUT THIS SEEMS TO BE UNPROBLEMATIC. LEVERING (MINIMALLY) AND ADVANCING THE INSTRUMENT, THERE IS A CRACKLING SOUND, THE SIGHT IS STILL THERE, BUT THE URS CANNOT BE ADVANCED ANY FURTHER. CAREFULLY PULLING OUT THE SCOPE, IT IS EMINENT IN THAT THE URS IS KINKED IN THE DISTAL END." THE PRODUCT WAS REPLACED DURING USE AND, ACCORDING TO THE CUSTOMER, THERE WAS A DELAY OF 10 MINUTES. THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10098414 ↗