S-LINE 8680225Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04055207042953), received between Jan 10, 2019 and May 14, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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. 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.

• 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 ↗
• 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 ↗
• 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 ↗