E-LINE 868895Recalls & reported problems
Richard Wolf GmbH · HOOK ELECTRODE MONO 9FR 0° for resectoscope, telescope Ø 1.9mm, electrode shape: hook, PACK=1 PC, for E-Line resectoscope, unsterile, reusable · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207011126), received between Jun 24, 2025 and Dec 1, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (3 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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation3
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE HOOK ELECTRODE BROKE IN THE PATIENT. THE BROKEN PART WAS TAKEN OUT WITH A DORMIA. THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 15-MINUTE DELAY IN SURGERY TIME, WITHOUT INJURY OR ENDANGERMENT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23681723 ↗InjuryJul 7, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING THE SURGICAL PROCEDURE, THE METAL HOOK BROKE OFF IN THE PATIENT'S BODY. THE MISSING FRAGMENT WENT OUT WITH THE INSTRUMENT AND NO MEDICAL FOLLOW-UP NEEDED. ALSO, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL UNSCHEDULED MEDICAL MEASURES. THERE WAS NO REPORT OF ANY PATIENT HARM.
Patient problems: Foreign Body In Patient
MAUDE report 22414252 ↗InjuryJun 24, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, DURING THE SURGICAL PROCEDURE, THE METAL HOOK BROKE OFF IN THE PATIENT'S BODY. THE MISSING FRAGMENT WAS IMMEDIATELY SEARCHED FOR IN THE BLADDER BUT COULD NOT BE FOUND. AN X-RAY WAS TAKEN TO IDENTIFY THE FRAGMENT, BUT WITHOUT SUCCESS. AN INDWELLING CATHETER WAS PLACED, AND POSTOPERATIVE FOLLOW-UP INCLUDED A CT SCAN A FEW DAYS LATER AND SURGICAL EXPLORATION TO LOCATE THE FRAGMENT. HOWEVER, IT ULTIMATELY REMAINED UNDETECTABLE.
Patient problems: Foreign Body In Patient
MAUDE report 22318548 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.