E-LINE 8655374Recalls & reported problems
Richard Wolf GmbH · OUTER SHEATH RESECTOSCOPE 26FR color code yellow, SL 191 mm, round, non-rotatable, distal end straight, continuous irrigation, compatible with inner sheath 8655.384 and telescopes Ø 4 mm, 0°, with irrigation stopcock, E-Line quick connection, 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 04055207018989), received between Mar 26, 2021 and Mar 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2021Difficult to Insert; Difficult to Insert
RW GMBH RECEIVED AND EVALUATED THE DEVICE. THE RESULTS OF THEIR INVESTIGATION: DURING THE INSPECTION IN THE SPECIALIST DEPARTMENT PA01-001-8674 OF THE SET SENT IN BY THE CUSTOMER CONSISTING OF: 8680.205 WORKING ELEMENT ACTIVE BIPO 0/12/30. 8655.374 OUTER SHEATH RESECTOSCOPE 26FR. 8655.384 INNER SHEATH RESECTOSCOPE 24CH. 8654.3742 CONNECTING PART FOR RESECTOSCOPE 24CH. THE OUTER SHEATH AND INNER SHEATH WERE FOUND TO BE BENT, CAUSING THE LOOP TO BE VISIBLE IN THE FIELD OF VIEW. THE OUTER SHAFT: 8655374 COMPLAINED ABOUT COMES FROM BATCH: 1277706 AND WAS ADDED TO THE STOCK ON 01.06.2015 WITH A BATCH SIZE OF 40 PIECES. THE PRODUCTION SCHEDULE WAS CHECKED AND NO ANOMALIES WERE REGISTERED. DELIVERY TO THE CUSTOMER TOOK PLACE ON 26.06.2015. NO COMPARABLE COMPLAINTS OCCURRED DURING THE PERIOD UNDER REVIEW. IN THE INSTRUCTIONS FOR USE GA-D345 / EN / 2018-03 V7.0 / PK18-9297, THE USER IS ADVISED OF THE LIMITED MECHANICAL LOAD CAPACITY IN CHAPTER 7 APPLICATIONS. IN ORDER TO BE ABLE TO DETECT DAMAGE TO THE PRODUCT AT AN EARLY STAGE, THE USER IS OBLIGED TO INSPECT THE INSTRUMENT FOR DAMAGE BEFORE AND AFTER USE (CHAPTER 8 INSPECTION). POSSIBLE HAZARDS WERE CONSIDERED IN THE RISK ASSESSMENT D3 R02
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574299 ↗
Other RESECTOSCOPE, WORKING ELEMENT devices
- S-LINE 8680224Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT7 reports
- E-LINE 86553841Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT7 reports
- S-LINE 8680225Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT5 reports
- S-LINE 8680204Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT5 reports
- S-LINE 8680205Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT1 death5 reports
- NA 8654282Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT3 reports
- PRINCESS 8653018Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT2 reports
- SHARK 8674225Richard Wolf GmbH · RESECTOSCOPE, WORKING ELEMENT2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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