MAUDE Adverse Event Report: RICHARD WOLF GMBH; CONNECTION CABLE WL 3M

Model Number	8564851
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Although no injuries or unacceptable risks to the patient were reported, richard wolf gmbh (rwgmbh) consider this case a "reportable malfunction" due to a similar incident being reported as a "serious injury" in the past two years.

• Common Device Name: CONNECTION CABLE WL 3M
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 25284387
• Report Number: 9611102-2026-00021
• Device Sequence Number: 9677450
• Product Code: GEY
• UDI-Device Identifier: 04055207066676
• UDI-Public: 04055207066676
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: B064839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8564851
• Device Catalogue Number: 8564.851
• Device Lot Number: 240398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown