SHARK 46782425Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04055207049044), received between Aug 13, 2018 and Feb 25, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2021Material Fragmentation; Material Fragmentation

  ADDITIONAL DETAILS RECEIVED BY RICHARD WOLF ABOUT THE DEVICES USED: ACCORDING TO THE SALES REP, THE SETTINGS USED: POWER SETTINGS 80/80. THAT MEANS 80 CUT AND 80 COAG. PICTURE OF THE GENERATOR USED DURING THE PROCEDURE IS ATTACHED AND FORWARDED TO RW GMBH FOR THE DEVICE INVESTIGATION. INVESTIGATION REPORT: DEVICE EVALUATION FROM RW GMBH. THE DEVICE WAS SENT TO RW GMBH FOR EVALUATION. FINDINGS: "THE DEVICES WERE INSPECTED IN THE RESPONSIBLE DEPARTMENT. THE RECEIVED INFORMATION ABOUT THE USED HF GENERATOR AND THE POWER SETTINGS WITHOUT THE INFORMATION ABOUT THE DURATION OF THE PROCEDURE AND THE USED PRODUCT COMBINATION IS NOT SUFFICIENT ENOUGH TO DETERMINATE THE CAUSE OF THE EVENT FURTHER. THREE ELECTRODES 46782425 CUTTING ELECTRODES MONO 24FR 12/30 WERE RECEIVED. ALL ELECTRODES SHOW DAMAGE TO THE DISTAL INSOLATION AND TWO ELECTRODES BROKE AT THE LOOP. IN ADDITION, ALL ELECTRODES ARE SEVERELY BENT AND IN TWO ELECTRODES THE REINFORCING TUBE IS DISPLACED. THE VISIBLE CHANGES ON THE ELECTRODES INDICATE MECHANICAL AND THERMAL-ELECTRICAL OVERLOADS. HOWEVER NO DEFINITIVE STATEMENT CAN BE CONCLUDED BASED ON THE AVAILABLE INFORMATION TO WHAT EXACTLY CAUSED THIS OVERLOAD. THE FURTHER DEFORMAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378672 ↗
• MalfunctionDec 16, 2020Material Rupture; Manufacturing, Packaging or Shipping Problem; Material Rupture; Manufacturing, Packaging or Shipping Problem

  FOR RESULTS OF THE DEVICE INVESTIGATION SEE THE MANUFACTURERS NARRATIVE.

  Patient problems: Insufficient Information

  MAUDE report 11020631 ↗
• MalfunctionSep 10, 2020Material Separation; Material Separation

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE PRODUCT HISTORY EVALUATION. THE DEVICE WAS NOT RETURNED BY THE USER FACILITY TO RW SO A REVIEW OF THE PRODUCT HISTORY (INVESTIGATION REPORT PRODUCT HISTORY EVALUATION) WAS COMPLETED BY THE MANUFACTURER. THE MANUFACTURER REPORTS: "WITHIN THE LAST THREE YEARS (>09.01.2018) RICHARD WOLF GMBH RECEIVED NO COMPLAINTS WITH THIS PRODUCT. DURING THIS TIME MORE THAN 580 PACKS (PACK = 10 PCS) ELECTRODES 46782424 HAVE BEEN SOLD WORLDWIDE WITHOUT ANY COMPLAINTS. ACCORDING TO OUR EXPERIENCE EXCESSIVE POWER SETTINGS ON THE HF GENERATOR CAN LEAD TO RAPID WEAR AND TEAR WHICH LEADS TO BREAKAGES OF DISTAL PARTS. TO AVOID SUCH DAMAGES DURING HF APPLICATION THE USER IS ADVISED IN THE INSTRUCTION MANUAL GA-D366 THAT EXCESSIVE POWER SETTING CAN LEAD TO SIGNIFICANTLY HIGHER ELECTRODE WEAR. DUE TO AN INCORRECTLY SELECTED HIF OUTPUT POWER INJURIES TO THE PATIENT AND DAMAGES OF THE PRODUCTS ARE POSSIBLE. AS THE EXISTING DATA DOES NOT SHOW ANY SIGNS OF SYSTEMATIC ERRORS OR ERRORS REGARDING THE MANUFACTURING NO FURTHER ACTION REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10516285 ↗
• MalfunctionJul 24, 2020Material Separation; Material Separation

  FOLLOW-UP REPORT #1. PLEASE REFER TO THE MANUFACTURER'S NARRATIVE FOR DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10320831 ↗
• MalfunctionAug 13, 2018Peeled/Delaminated

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, HEREIN AFTER REFERRED TO AS RWMIC, WAS MADE AWARE BY AN INDEPENDENT SALES AGENT ON (B)(6) 2018 THAT THE USER FACILITY (ON AN UNSPECIFIED DATE) EXPERIENCED AN ISSUE WITH PLASTIC PEELING OFF THE LOOP OF THE ELECTRODE. THE ISSUE WAS OBSERVED DURING PROCEDURE ON A PATIENT WHO WAS UNDER GENERAL ANESTHESIA. THERE WAS A DELAY IN THE PROCEDURE BEING PERFORMED WHICH MAY HAVE PUT THE PATIENT AT RISK, HOWEVER, NO INJURY OR ADVERSE OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT. A BACKUP DEVICE WAS READILY AVAILABLE AND THE PROCEDURE WAS PERFORMED AS SCHEDULED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7778743 ↗
• MalfunctionAug 13, 2018Peeled/Delaminated

  RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, HEREIN AFTER REFERRED TO AS RWMIC, WAS MADE AWARE BY AN INDEPENDENT SALES AGENT ON (B)(6) 2018 THAT THE USER FACILITY (ON AN UNSPECIFIED DATE) EXPERIENCED AN ISSUE WITH PLASTIC PEELING OFF THE LOOP OF THE ELECTRODE. THE ISSUE WAS OBSERVED DURING PROCEDURE ON A PATIENT WHO WAS UNDER GENERAL ANESTHESIA. THERE WAS A DELAY IN THE PROCEDURE BEING PERFORMED WHICH MAY HAVE PUT THE PATIENT AT RISK, HOWEVER, NO INJURY OR ADVERSE OUTCOME WAS REPORTED AS A RESULT OF THIS INCIDENT. A BACKUP DEVICE WAS READILY AVAILABLE AND THE PROCEDURE WAS PERFORMED AS SCHEDULED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7778699 ↗