E-LINE 86500445Recalls & reported problems
Richard Wolf GmbH · SHEATH FOR CYSTOSCOPE 21FR color code blue, SL 231mm, oval, slanted distal end, capacity for instruments up to 10Fr or 2x 6Fr, compatible with attachments 8650254, 8650264, 8650.284, and telescopes Ø 4mm, with 2 flushing ports, quick-lock, 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207027899), received between Jan 13, 2020 and Jan 13, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2020Material Integrity Problem; Material Integrity Problem
ON 31 OCTOBER 2019, RICHARD WOLF (B)(4) RECEIVED THE FOLLOWING INFORMATION: THE CUSTOMER INFORMED BY TELEPHONE THAT DAMAGE TO THE PATIENT HAS OCCURRED DUE TO THE USE OF THE INSTRUMENT WITHIN THE SCOPE OF AN OPERATION. THE SHAFT FOR CYSTOSCOPE 21CH, TYPE 86500445 IS SAID TO HAVE HAD A BURR, RESULTING IN A PERFORATION ON THE PATIENT. DETAILED WRITTEN INFORMATION ABOUT THE EVENT OR THE PATIENT INJURY DAMAGE WAS NOT PROVIDED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS FOUND THAT THE DEVICE SHAFT SHOWS ONLY SLIGHT SIGNS OF WEAR: NO DENTS ON THE OUTER WALL OF THE SHAFT TUBE THE SHAFT TUBE IS NOT BENT. SHEATH TUBE DIAMETER AND MOUNTING HOLE IN THE ROTATING LOCKING PART ARE DIMENSIONALLY ACCURATE - NO TOLERANCE DEVIATION VERIFIABLE. DISTAL END IS BURR-FREE AND SUFFICIENTLY ROUNDED. THE LASER MARKING ON THE PRODUCT IS STILL CLEARLY LEGIBLE. THE BRASS FLUSHING TAPS LOCATED ON THE ROTARY PLUG ARE STILL COMPLETELY FUNCTIONAL. ADHESIVE CONNECTION ON THE SCREW CAP OF THE DRAIN COCK IS COMING LOOSE ON ONE SIDE. THERE WERE NO SIGNS OF IMPROPER USE NOTED. THE CHROMIUM-PLATED BRASS FLUSH TAPS AND THE BATCH NUMBERS INDICATE THE INSTRUMENT HAD BEEN IN USE FOR SOME TIME (APPROXI
Patient problems: Perforation
MAUDE report 9583472 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page