S-LINERecalls & reported problems across all models

We found 4 models of S-LINE by Richard Wolf GmbH in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and Apr 8, 2026 — classified as 1 death, 12 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Grounding Malfunction” (3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported S-LINE problems

S-LINE models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• S-LINE 8680224

  RESECTOSCOPE, WORKING ELEMENT
  7 reports
• S-LINE 8680204

  RESECTOSCOPE, WORKING ELEMENT
  5 reports
• S-LINE 8680205

  RESECTOSCOPE, WORKING ELEMENT
  1 death5 reports
• S-LINE 8680225

  RESECTOSCOPE, WORKING ELEMENT
  5 reports

Recent S-LINE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Material Twisted/Bent

  THE CUSTOMER STATED THAT THE HANDLE ON THE WORKPIECE IS BENT, PREVENTING THE HF LOOP FROM BEING MOVED ALL THE WAY TO THE END. THE SURGERY COULD NOT BE COMPLETED. THE USER DID NOT PROVIDE ANY INFORMATION REGARDING THE PATIENT'S CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 24821595 ↗
• InjuryApr 8, 2026Material Twisted/Bent

  THE CUSTOMER STATED THAT THE HANDLE ON THE WORK PIECE IS BENT, PREVENTING THE HF LOOP FROM BEING MOVED ALL THE WAY TO THE END. THE SURGERY COULD NOT BE COMPLETED. THE USER DID NOT PROVIDE ANY INFORMATION REGARDING THE PATIENT'S CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 24821580 ↗
• 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 ↗
• InjuryMay 14, 2024Intermittent Energy Output; Intermittent Energy Output

  RICHARD WOLF GMBH HAS BEEN INFORMED OF AN ISSUE REGARDING A WORKING ELEMENT PASSIVE BIPO 0/12/30°, PART ID: 8680.225, LOT# 1546598. ACCORDING TO THE RECEIVED INFORMATION, DURING A SURGICAL PROCEDURE THE CONDUCTION OF ENERGY THAT GOES FROM THE WORKING ELEMENT TO THE CUTTING HANDLE WAS DEFICIENT. TO COUNTERACT THIS DEFICIENCY THE PARAMETERS OF THE GENERATOR HAD TO BE INCREASED. THIS SOLUTION WORKED DURING THE SURGERY, WHICH ALLOWED THE PROCEDURE TO BE COMPLETED. BECAUSE OF THIS FAILURE, THE SURGERY TIME WAS EXTENDED FOR MORE THAN 60 MINUTES. WITH THE INFORMATION CURRENTLY AVAILABLE TO RWGMBH FROM THE QUESTIONNAIRE ON INCIDENT (B)(4), NO PATIENT INJURY OR PATIENT RISK IS APPARENT. IN ADDITION, NO OTHER UNEXPECTED SIDE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311138 ↗
• MalfunctionFeb 7, 2024Overheating of Device; Material Separation; Overheating of Device; Material Separation

  A USER FACILITY HAS INFORMED RICHARD MEDICAL INSTRUMENTS CORPORATION (RWMIC) OF AN ISSUE REGARDING A WORKING ELEMENT PASSIVE BIPO 0/12/30°, PART ID: 8680.225, LOT# 1285560. ACCORDING TO THE RECEIVED INFORMATION, AT THE BEGINNING OF A TRANSURETHRAL RESECTION OF BLADDER TUMOR THE MEDICAL DOCTOR, REGISTERED NURSE, AND SURGICAL TECHNOLOGIST REPORTED A LOUD POP FROM THE DEVICE OCCURRED WHILE IN THE PHYSICIAN'S HAND. THIS CAUSED A FEW MINUTES DELAY DURING THE OPERATION. A BACK-UP DEVICE WAS RETRIEVED TO COMPLETE THE SCHEDULED PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660542 ↗
• MalfunctionNov 9, 2023Overheating of Device; Smoking; Unintended Electrical Shock; Overheating of Device; Smoking; Unintended Electrical Shock

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A WORKING ELEMENT PASSIVE BIPO 0/12/30°, PART ID: 8680.225, LOT # 1499179. ACCORDING TO THE RECEIVED INFORMATION, THE WORKING ELEMENT OVERHEATED AND HAS BURN MARKS ON IT. THE WORKING ELEMENT PASSED CURRENT TO THE PHYSICIAN AND THEN SMOKED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 15-20 MINUTE DELAY MID-CASE TO RETRIEVE A BACK-UP DEVICE. THE SCHEDULED PROCEDURE WAS COMPLETED.

  Patient problems: Electric Shock

  MAUDE report 18100483 ↗
• 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 ↗
• InjuryMar 21, 2023Sparking; Electrical Shorting; Sparking; Electrical Shorting

  A USER FACILITY REPRESENTATIVE HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A WORKING ELEMENT PASSIVE BIPO 0/12/30°, PART ID: 8680.225, BATCH # 1474987. THE USER FACILITY CLAIMED THAT "DURING A SURGICAL PROCEDURE OF TRANSURETHRAL RESECTION OF THE PROSTATE (TURP), WHEN ACTIVATING THE CUTTING FUNCTION ON THE ERBE ELECTROSURGICAL SCALPEL, THE WORKING ELEMENT OCCURRED A SHORT AND SPARKED, THUS BURNING THE SURGICAL INSTRUMENT PART ID: 8680.225 S/N: (B)(4). USED ELECTRODES: REF: 4622.1313 LOT: 1492598 AND REF: 4623.0223 LOT: 4500358239.". ADDITIONAL INFORMATION FROM THE USER FACILITY WAS RECEIVED ON 18/OCT/2022: "IT WAS NOT POSSIBLE TO VERIFY EXACTLY WHERE THE FIRE STARTED DUE TO THE SPEED OF THE EVENT AND THE TENSION OF THE MOMENT, BUT THE DOCTOR'S HAND BURNED".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burn(s); Unspecified Tissue Injury

  MAUDE report 16582857 ↗
• 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 ↗
• MalfunctionJun 8, 2021Unintended Electrical Shock; Unintended Electrical Shock

  THE PURPOSE OF THIS REPORT IS TO REPORT THE DEVICE EVALUATION/INVESTIGATION RESULTS. PLEASE SEE MANUFACTURERS NARRATIVE.

  Patient problems: Electric Shock

  MAUDE report 11957808 ↗
• DeathSep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 11, 2019, RICHARD WOLF (B)(4) RECEIVED THE FOLLOWING INFORMATION: A PATIENT DEATH WAS REPORTED BY THE HOSPITAL (B)(6) IN (B)(6) WHERE AN S-LINE RESECTOSCOPE WORKING ELEMENT AND ACCESSORIES WERE BEING USED DURING A PROCEDURE, TRANSURETHRAL RESECTION OF THE BLADDER. THE BLADDER OF THE PATIENT WAS REPORTED TO HAVE BEEN FILLED WITH SODIUM CHLORIDE (NACL) SOLUTION. DURING THE RESECTION (NOT IN THE IGNITION PHASE), THE BLADDER BURST AND CAUSED A PELVIC ARTERY TO TEAR. THIS HAPPENED ALMOST AT THE END OF THE SURGICAL PROCEDURE. AN UNSUCCESSFUL EMERGENCY OPERATION WAS CARRIED OUT FOR OVER APPROXIMATELY THREE(3) HOURS, WITH FOUR (4) DOCTORS PRESENT. THE PATIENT EXPIRED DURING THE EMERGENCY OPERATION. THE PATIENT WAS (B)(6) YEARS OLD AND WAS IN NORMAL, GOOD STATE OF HEALTH. THERE WAS NO INFORMATION AVAILABLE REGARDING THE QUANTITY OF NACL USED OR ABOUT THE FLUSHING PRESSURE. THE POSITION OF THE NACL BOTTLE WAS APPROXIMATELY 1M ABOVE THE OPERATING TABLE WITHOUT A PUMP. IT IS CURRENTLY NOT KNOWN HOW LONG THE RESECTION TOOK.

  Patient problems: Death

  MAUDE report 9050559 ↗
• InjuryFeb 22, 2019Temperature Problem; Temperature Problem

  ON NOVEMBER 07, 2018, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED A REPORT FROM RICHARD WOLF (B)(4) INVOLVING THE FOLLOWING DEVICES: 815.052 LOT 523/573 (MDR 9611102-2018-00015), 815.032 LOT 006/086 (MDR 9611102-2018-00016), 8674.205 LOT 1259038 (MDR 9611102-2018-00017), 8680.205 LOT 1255367 (THIS MDR), 8654.204 LOT 1202777 (MDR 9611102-2018-00019). IT WAS REPORTED THAT THE PATIENT SUFFERED THIRD DEGREE BURN ON THE RIGHT FINGER DUE TO HF APPLICATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INSPECTION SHOWED THAT THE CAUSE OF THE FAULT DESCRIBED BY THE USER CANNOT BE TRACED BACK TO THE WORKING ELEMENTS OR HF CONNECTION CABLE MONO. PROBABLE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. NO DEFECTS WERE FOUND IN THE MEDICAL DEVICES. IN CONCLUSION, THE COMBUSTION WAS NOT CAUSED BY A FAULTY HF DEVICE OR ACCESSORY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8363751 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) WAS SERVED WITH A PATIENT LAWSUIT INVOLVING A "BUTTON TYPE BIPOLAR PROSTATE RESECTOR AND/OR ELECTROSURGICAL GENERATOR". ON (B)(6) 2016, THE PATIENT UNDERWENT A PROCEDURE DESCRIBED AS "CYSTOSCOPY WITH URETHRAL DILATION, TRANSURETHRAL RESECTION/ABLATION OF PROSTATE WITH BIPOLAR". DURING SAID PROCEDURE, THE PATIENT WAS UNDER GENERAL ANESTHESIA AND SUFFERED THERMAL INJURY TO THEIR BLADDER AND URETHRA. AT THIS TIME, THE INVOLVEMENT OF RICHARD WOLF PRODUCTS HAS NOT BEEN CONFIRMED. HOWEVER, THE FOLLOWING ARE CONSIDERED SUSPECT PRODUCTS AND MDRS WILL BE SUBMITTED FOR EACH UNTIL THE USER FACILITY IS ABLE TO CONFIRM THAT NO RICHARD WOLF PRODUCTS WERE INVOLVED: 8680.225 WORKING ELEMENT PASSIVE BIPO 0/12/30 (MDR), 8680.224 WORKING ELEMENT PASSIVE BIPO 0/12/30 (MDR 1418479-2018-00052), 46300223 BIVAP ELECTRODE BIPO 22FR 12/30 (MDR 1418479-2018-00053), 46300243 BIVAP ELECTRODE BIPO 24-26FR 12/30 (1418479-2018-00054).

  Patient problems: Burn, Thermal

  MAUDE report 8238005 ↗

Other Richard Wolf GmbH products

• PIRANHA6 models · 66 reports
• SHARK10 models · 62 reports
• PIEZOWAVE23 models · 4 reports · 1 recall
• SHARK/S-LINE11 models · 48 reports
• E-LINE19 models · 38 reports
• ERAGON MODULAR16 models · 29 reports
• PANOVIEW10 models · 24 reports