S-LINE 8680204Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207042922), received between Apr 21, 2022 and Feb 19, 2026 — classified as 3 injuries, 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Use of Device Problem; Explosion

  THE USER REPORTS THAT UPON ACTIVATION OF THE CUTTING CURRENT AND CONTACT WITH AN AIR BUBBLE, BLADDER EXPANSION OCCURS FOLLOWED BY BLADDER DETONATION. PLANNED PROCEDURE WAS CYSTOLITHOTRIPSY. DUE TO A LARGE AMOUNT OF INFECTION AND TISSUE, A RESECTOSCOPE SHARK BIPOLAR WAS INITIALLY USED TO REMOVE THIS TISSUE. THE PATIENT SUSTAINED A BLADDER PERFORATION IN THE AREA OF THE BLADDER VERTEX. ON THE FOLLOWING DAY, A LAPAROTOMY WAS PERFORMED. THE PATIENT'S CONDITION HAS BEEN STABILIZED AND THE DAMAGE WAS REPAIRED.

  Patient problems: Perforation

  MAUDE report 24394198 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING BIPOLAR PROSTATE RESECTION, THE PATIENT DEVELOPED PULMONARY EMBOLISM. THE OPERATION TIME WAS PROLONGED. HOWEVER, THE SCHEDULED PROCEDURE WAS COMPLETED. THE PATIENT WAS KEPT IN AN EMERGENCY/HOSPITAL AND WAS ABLE TO LEAVE THE HOSPITAL.

  Patient problems: Air Embolism

  MAUDE report 21403369 ↗
• InjuryOct 25, 2023Material Separation; Material Separation

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A WORKING ELEMENT ACTIVE BIPO 0/12/30°, PART ID: 8680.204, LOT # 1476165. ACCORDING TO THE RECEIVED INFORMATION, THE DEVICE WAS BROKEN PROXIMALLY DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), DURING WHICH A PART OF THE PROSTATE DISEASED TISSUE WAS RESECTED, FROM PROSTATE. IT HAPPENED DURING THE RESECTION OF THE TISSUE. THE PATIENT HAS MODERATE BLEEDING, WHICH IS IMPROVED BY TRACTION WITH A FOLLEY CATHETER. DUE TO THE BREAK OF THE INSTRUMENT, THE OPERATION TIME HAS BEEN PROLONGED BY ONE(1) HOUR. NOW THE PATIENT IS DOING WELL. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE SCHEDULED SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 18004395 ↗
• MalfunctionDec 19, 2022Arcing of Electrodes; Unintended Electrical Shock; Arcing of Electrodes; Unintended Electrical Shock

  RICHARD WOLF GMBH REFERENCE: (B)(4). RICHARD WOLF GMBH IN (B)(4) (MANUFACTURER) WAS INFORMED ABOUT THE FOLLOWING: DESCRIPTION OF INCIDENT/CLAIM ACCORDING TO THE CUSTOMER: "ON (B)(6) 2022 SCHEDULED INTERVENTION: ENDOSCOPIC RESECTION OF THE PROSTATE. ALL CONNECTIONS WERE CORRECT, THE RIGHT MODE/PROGRAM "BIPOLAR RTUP". THE SURGEON INDUCES THE RESECTOR, STARTS THE "SECTIONING" OF THE PROSTATE AND THE PATIENT ON JUMPS LIKE AN EXTERNAL SHOCK OR ELECTROSTIMULATION. ALERTING THE REGULATOR AND THE EXECUTIVE WHO CAME DIRECTLY. MOREOVER IT IS THE SECOND UNDESIRABLE EVENT IN THE SAME ROOM, ON THE SAME INTERVENTION THAT OCCURRED ON (B)(6) 2022. YESTERDAY THE INTERCOM WAS TRIGGERED SEVERAL TIMES JUST BEFORE THE ARC AND TODAY WE NOTICE THE GENERAL LIGHTING OF THE ROOM THAT FLASHES IN AN UNSYSTEMATIC WAY." THE USER INFORMED THAT THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTIES. THE USER STATED TO REPORT IT TO ANSM. RWGMBH MDR AWARENESS DATE: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009294 ↗
• MalfunctionApr 21, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION.

  Patient problems: Insufficient Information

  MAUDE report 14166307 ↗