SHARK/S-LINE 8108252Recalls & reported problems
Richard Wolf GmbH · HF BIPOLAR CONNECTING CABLE L 5M for ERBE generators, reusable · Class 2
All models of SHARK/S-LINE (11)
Data updated Oct 18, 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 04055207000922), received between Aug 28, 2018 and Aug 28, 2018 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
- Fire1
- Power Problem1
- Structural Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2018Break; Fire; Structural Problem; Power Problem
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, HEREINAFTER REFERRED TO AS RWMIC WAS NOTIFIED ON 8/23/2018 BY RICHARD WOLF (B)(4), HEREINAFTER REFERRED TO AS RW(B)(4) OF AN INCIDENT THAT OCCURRED ON (B)(6) 2018. THE USER FACILITY REPORTED THAT DURING THE USE (CUTTING COAGULATION MODE) BY THE DOCTOR THAT THE RESECTOSCOPE STOPPED WORKING IN THE MIDDLE OF THE OPERATION AND IGNITED THE TISSUES. THE FLAMES CAUSED SEVERE BURNS ON THE PATIENT. FIRST INVESTIGATIONS SHOWED THAT A BREAKAGE OF THE CABLE HAD OCCURRED. THE ISOLATION OF THE CABLE WAS DAMAGED AT THE BREAK SO THAT THE STRAND WAS EXPOSED.
Patient problems: Burn(s)
MAUDE report 7824438 ↗
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- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22305DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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