NA 815053Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207000274), received between May 23, 2023 and Nov 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fire” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Sparking; Electrical Shorting; Sparking; Electrical Shorting

  THE USER FACILITY HAS INFORMED RICHARD WOLF GMBH OF AN ISSUE REGARDING A HF CONNECTION CABLE MONO L 5M, PART ID: 815.053, SN/BATCH# UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, DURING RESECTION OF THE BLADDER TUMOR, WOLF CAUTERY CORD EXPLODED IN HALF AND RELEASED SPARKS. THERE WAS NO PROLONGATION OF THE OPERATION TIME NOR ANY DANGER TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18121718 ↗
• MalfunctionMay 23, 2023Fire; Fire

  ON (B)(6) 2023, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED A MEDWATCH REPORT # (B)(4) REGARDING A WORKING ELEMENT PASSIVE MONO 12/30° PART 8674225, BATCH # UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, "WHILE USING THE RESECTOSCOPE. APPARENT THERE WAS A FIRE ON THE HAND PIECE TO THE RESECTOSCOPE DURING A PROSTATE PROCEDURE. NO HARM TO THE PATIENT OR SURGEON DURING THE EVENT. THE WORKING ELEMENT CAUGHT ON FIRE DURING USE." IT IS SUSPECTED THAT THE HF CONNECTION CABLE MONO L 5M, PART ID: 815.053, BATCH # UNKNOWN, WITHIN THE HAND PIECE (WORKING ELEMENT PASSIVE MONO 12/30° PART 8674225, BATCH # UNKNOWN) IS WHAT HAD IGNITED. THE REPORTED ISSUE CAUSED A 15 MINUTE DELAY IN THE PROCEDURE WHILE THE FIRE WAS PUT OUT AND THE BACK-UP DEVICE 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 16989005 ↗
• MalfunctionMay 23, 2023Fire; Fire

  ON (B)(6) 2023, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED A MEDWATCH REPORT # (B)(4) REGARDING A WORKING ELEMENT PASSIVE MONO 12/30° PART 8674225, BATCH # UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, "WHILE USING THE RESECTOSCOPE. APPARENT THERE WAS A FIRE ON THE HAND PIECE TO THE RESECTOSCOPE DURING A PROSTATE PROCEDURE. NO HARM TO THE PATIENT OR SURGEON DURING THE EVENT. THE WORKING ELEMENT CAUGHT ON FIRE DURING USE." IT IS SUSPECTED THAT THE HF CONNECTION CABLE MONO L 5M, PART ID: 815.053, BATCH # UNKNOWN, WITHIN THE HAND PIECE (WORKING ELEMENT PASSIVE MONO 12/30° PART 8674225, BATCH # UNKNOWN) IS WHAT HAD IGNITED. THE REPORTED ISSUE CAUSED A 15 MINUTE DELAY IN THE PROCEDURE WHILE THE FIRE WAS PUT OUT AND THE BACK-UP DEVICE 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 16988946 ↗