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E-LINE 8708517Recalls & reported problems

Richard Wolf GmbH · URETERORENOSCOPE 5° 6.5/8.5FR WL 330MM semi-rigid, with straight ocular lens, working channel 1: 1x4 (2x2.2)Fr, working channel 2: 2.4Fr, atraumatic distal tip, TL 473mm, fiber image carrier, reusable · Class 2

All models of E-LINE (19)

Data updated Oct 16, 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 04055207063323), received between Aug 9, 2019 and Aug 9, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 9, 2019Break; Break

    ON (B)(6) 2019, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED VOLUNTARY EVENT REPORT # MW5087618. IT WAS REPORTED THAT THE 4 FRENCH PORT ON THE WOLF SEMI RIDGED SCOPE WAS OCCLUDED BY DEBRIS CAUSING THE TIP OF THE 0 TOP BASKET TO SHEAR OFF IN THE PATIENT. FOREIGN BODY RETRIEVAL BY DOCTOR WAS SUCCESSFUL. PATIENT WAS NOT HARMED. USER FACILITY FEELS THE DEVICE WAS NOT PROPERLY CLEANED AND HANDLED DOWN IN PREP AND STERILE.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 8881273 ↗

Other Ureteroscope and accessories, flexible/rigid devices

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Sources and updates

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