NA 8564851Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207066676), received between Oct 4, 2024 and May 26, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Disconnection

  IT WAS REPORTED THAT THE PLUGGED CORD ATTACHED TO THE MOTOR AND THE CONSOLE WOULD NOT REGISTER THE PRESENCE OF THE MOTOR DURING A PROCEDURE. NO INJURIES OR UNACCEPTABLE RISKS WERE REPORTED. THERE WAS A SIMILAR BACK UP INSTRUMENT AVAILABLE. NO ADDITIONAL TREATMENT WAS REQUIRED AND THE SCHEDULED PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284387 ↗
• MalfunctionAug 6, 2025Connection Problem; Connection Problem

  THE USER REPORTED THAT THE CONNECTION CABLE DID NOT WORK DURING AN ARTHROSCOPY PROCEDURE. THERE WAS NO REPORT OF ANY HARM TO THE PATIENT, USERS, OR THIRD PARTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730420 ↗
• InjuryOct 4, 2024Disconnection; Disconnection

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL CORPORATION (RWMIC) OF AN ISSUE REGARDING A CONNECTION CABLE WL 3M, PART ID: 8564.851, BATCH# 230372. ACCORDING TO THE RECEIVED INFORMATION, THE USER INDICATED THAT THE CONNECTION BETWEEN THE MOTOR CONTROL UNIT, CONNECTION CABLE, AND THE HANDPIECE HAD BEEN INTERRUPTED. DUE TO IT, THE MOTOR CONTROL UNIT FAILED TO RECOGNIZE THE HANDPIECE. THE CONNECTION CABLE WAS CHECKED, AND NO BENT PINS WERE FOUND. THE REPORTED EVENT HAPPENED ON A THIRD CASE, AT THE BEGINNING OF A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE BUT PRIOR TO BEING USED ON THE PATIENT. HOWEVER, THERE WAS A REPORTED 15-MINUTE DELAY TROUBLESHOOTING THE DEVICE. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS BROUGHT BACK 2 DAYS LATER FOR MORCELLATION. ANOTHER CONNECTION CABLE WAS USED, AND IT WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369024 ↗
• InjuryOct 4, 2024Disconnection; Disconnection

  THE USER FACILITY HAS INFORMED RICHARD WOLF MEDICAL CORPORATION (RWMIC) OF AN ISSUE REGARDING A CONNECTION CABLE WL 3M, PART ID: 8564.851, BATCH# 230372. ACCORDING TO THE RECEIVED INFORMATION, THE USER INDICATED THAT THE CONNECTION BETWEEN THE MOTOR CONTROL UNIT, CONNECTION CABLE, AND THE HANDPIECE HAD BEEN INTERRUPTED. DUE TO IT, THE MOTOR CONTROL UNIT FAILED TO RECOGNIZE THE HANDPIECE. THE CONNECTION CABLE WAS CHECKED, AND NO BENT PINS WERE FOUND. THE REPORTED EVENT HAPPENED ON A THIRD CASE, AT THE BEGINNING OF A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE BUT PRIOR TO BEING USED ON THE PATIENT. HOWEVER, THERE WAS A REPORTED 15-MINUTE DELAY TROUBLESHOOTING THE DEVICE. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS BROUGHT BACK 2 DAYS LATER FOR MORCELLATION. ANOTHER CONNECTION CABLE WAS USED, AND IT WORKED FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20368896 ↗