SHARK/S-LINE 46222513Recalls & reported problems
Richard Wolf GmbH · CUTTING ELECTRODE BIPO 24-26FR 12/30° for Shark resectoscopes, telescope Ø 4 mm, suitable for sheaths from 24 Fr, loop: round, wire Ø 0.25 mm, PACK = 3 pcs., sterile, in individual packaging, for single use · Class 2
All models of SHARK/S-LINE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207048887), received between Mar 2, 2018 and Apr 10, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- Device Embedded In Tissue or Plaque2
- 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.
MalfunctionApr 10, 2024
AS SOON AS THE CURRENT WAS APPLIED, THE DEVICE POPPED AND BROKE. ONCE THIS HAPPENED, NO LONGER ABLE TO USE THE RESECTOSCOPE AFTER THIS EVENT OCCURRED. THE SCOPE WAS TAKEN OUT OF SERVICE AND SENT TO STERILE PROCESSING DEPARTMENT FOR REPAIRS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19078527 ↗MalfunctionMar 2, 2018Material Fragmentation; Material Fragmentation
DURING THE USE, THE WIRE LOOP ELECTRODE DETACHED AND REMAINED IN THE UTERUS OF THE PATIENT. SECOND ELECTRODE WAS USED AND DETACHED AND REMAINED IN UTERUS. TWO MDRS TO BE SUBMITTED: 9611102-2018-00002, 9611102-2018-00003.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 7311132 ↗MalfunctionMar 2, 2018Material Fragmentation; Material Fragmentation
DURING THE USE, THE WIRE LOOP ELECTRODE DETACHED AND REMAINED IN THE UTERUS OF THE PATIENT. SECOND ELECTRODE WAS USED AND DETACHED AND REMAINED IN UTERUS. TWO MDRS TO BE SUBMITTED: 9611102-2018-00002, 9611102-2018-00003.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 7311124 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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