SHARK 8675426Recalls & reported problems
Richard Wolf GmbH · OUTER SHEATH RESECTOSCOPE 26FR SL 189 mm, round, rotatable, distal end straight, continuous irrigation, compatible with Shark inner sheath 8675324, and telescopes Ø 4 mm, 0°/12°/30°, Snap-On lock, reusable · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207019672), received between Jun 23, 2023 and Jul 3, 2024 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Insufficient Device Problem Information1
- Material Twisted/Bent1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2024Material Twisted/Bent; Material Twisted/Bent
RICHARD WOLF GMBH HAS BEEN INFORMED OF AN ISSUE REGARDING AN OUTER SHEATH RESECTOSCOPE 26FR, PART ID: 8675426, LOT# 1381365. ACCORDING TO THE RECEIVED INFORMATION, "WHEN PERFORMING A TRANSURETHRAL RESECTION (TUR) OF THE BLADDER, THE SHAFT OF THE DEVICE WAS BENT. THIS RESULTED IN A LESION OF THE URETHRA. AS A RESULT, THE OPERATING TIME WAS EXTENDED BY 2 HOURS AND ADDITIONAL UNSCHEDULED MEDICAL MEASURES HAD TO BE TAKEN." THE SCHEDULED SURGICAL PROCEDURE WAS COMPLETED AND NO ADDITIONAL SURGERY WAS PERFORMED.
Patient problems: Unspecified Kidney or Urinary Problem
MAUDE report 19666367 ↗MalfunctionJun 23, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
A USER FACILITY HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING AN OUTER SHEATH RESECTOSCOPE 26FR SL 189MM, PART ID: 8675426, LOT # UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, DURING AN ENDOSCOPIC SURGICAL PROCEDURE FOR A PROSTATIC ADENOMA, THE URETHRAL SHEATH, PART ID: 8675426, BROKE OFF INSIDE THE PATIENT'S URETHRA. THERE WAS DIFFICULTY IN PULLING OUT THE URETHRAL SHEATH AND THE PATIENT REPORTEDLY BLED DURING THE PROCESS. ADDITIONALLY, IT WAS DETERMINED THAT THE SURGICAL PROCEDURE WAS EXTENDED. THE PROCEDURE INCLUDES BOTH DEVICES URETHRAL SHEATH REF. 8675426, AND INNER SHEATH REF. 8675524.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information
MAUDE report 17192620 ↗
Other RESECTOSCOPE devices
- Olympus A22040AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall1,764 reports
- Olympus A42011AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall963 reports
- Olympus A22041AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall656 reports
- Olympus A22042AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall55 reports
- Olmypus WA22017AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall31 reports
- Olympus A22040TOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall23 reports
- Olympus A22041TOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall12 reports
- Olympus A22014AOLYMPUS Winter & Ibe GmbH · Resectoscope1 recall11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.