SHARK/S-LINE 8622133Recalls & reported problems
Richard Wolf GmbH · CUTTING ELECTRODE BIPO 22FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, continuous irrigation, 22/24, Fr, loop: round, wire Ø 0.3mm, fork color blue, stem color yellow, PACK=1 PC, for Shark and S-Line Resectoscopes, unsterile, reusable · Class 2
All models of SHARK/S-LINE (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207018026), received between May 26, 2021 and Sep 4, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Arcing of Electrodes” (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.
Reports received per month
Most reported problems
Device problems
- Arcing of Electrodes1
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Material Fragmentation1
- Material Separation1
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
RICHARD WOLF GMBH HAS BEEN INFORMED OF AN ISSUE REGARDING A CUTTING ELECTRODE BIPO 22FR 12/30°, PART ID: 8622133, BATCH# 21004873. ACCORDING TO THE RECEIVED INFORMATION, DURING A HYSTEROSCOPY RESECTION, THE ELECTRODE WAS BURNT THROUGH ONE SIDE AT THE END OF THE ARCH. THE HOSPITAL REPORTED THAT THERE WAS NO LOUD SOUND, JUST THE LIGHT WAS BRIGHTER THAN USUAL. THE SURGEON SEARCHED FOR A FRAGMENT OF THE LOOP TIP FOR ABOUT 30 MINUTES JUST IN CASE, BUT NO FRAGMENT WAS FOUND. THE USER REPORTED THE OPERATION WAS COMPLETED WITH A REPLACEMENT AND THERE WAS NO PATIENT INJURY AS A RESULT OF THE INCIDENT.
Patient problems: Insufficient Information
MAUDE report 20138978 ↗MalfunctionOct 4, 2023Material Fragmentation; Arcing of Electrodes; Material Fragmentation; Arcing of Electrodes
RICHARD WOLF (B)(6) HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A CUTTING ELECTRODE BIPO 22FR 12/30°, PART ID: 8622133, LOT #21004154. ACCORDING TO THE RECEIVED INFORMATION, THE CUTTING ELECTRODE SPARKED AND BROKE DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) SURGERY. BECAUSE OF THIS, THE CERAMIC TIP (PART ID: 8675322) ON THE INNER SHAFT BROKE. THE BROKEN PART OF THE CERAMIC TIP WAS RETRIEVED. THERE WAS A REPORTED OR TIME EXTENSION OF 15 MINUTES. THE SCHEDULED PROCEDURE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 17869654 ↗MalfunctionDec 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ON NOVEMBER 29, 2021 RICHARD WOLF WAS INFORMED BY THE CUSTOMER. THE CUSTOMER HAS REPORTED THAT THE LOOP CAME LOOSE IN THE UTERUS DURING A RESECTION. THE LOOP WAS RECOVERED AND THE ELECTRODE WAS KEPT FOR TECHNICAL EXPERTISE IF NECESSARY. THE RICHARD WOLF (B)(4) WAS REPLACED, BUT THE TREATMENT COULD NOT BE COMPLETED. CONSEQUENCES FOR PATIENT, USER OR OTHER PERSON IS THAT A NEW SURGERY IS POSSIBLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 13091000 ↗MalfunctionMay 26, 2021Material Separation; Material Separation
THE PURPOSE OF THIS REPORT IS TO SUBMIT THE RESULTS OF THE DEVICE INVESTIGATION. PLEASE SEND MANUFACTURERS NARRATIVE FOR DETAILS.
Patient problems: Foreign Body In Patient
MAUDE report 11890343 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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