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	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information, richard wolf consider this case to be a reportable "serious injury" due to "aborted procedure".
Event or Problem Description
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.

• Common Device Name: CONNECTION CABLE WL 3M
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 20368896
• Report Number: 1418479-2024-00008
• Device Sequence Number: 11734851
• Product Code: GEY
• UDI-Device Identifier: 04055207066676
• UDI-Public: 04055207066676
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2024
• Report Date (Section F): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8564851
• Device Catalogue Number: 8564.851
• Device Lot Number: 230372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2024
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE: POWER STICKS.; MOTOR CONTROL UNIT: POWER DRIVE ART1.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/04/2024