MAUDE Adverse Event Report: RICHARD WOLF GMBH POWER CONTROL; MOTOR CONTROL UNIT 2303

Model Number	2303011
Medical Device Problem Codes	Failure to Cut (2587); Poor Visibility (4072)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility has informed richard wolf medical instruments corporation (rwmic) of an issue, at the start of morcellation during a holmium laser enucleation of the prostate (holep) procedure, the blades were not biting any of the tissue nor sucking the tissue toward the blades.During this time, visualization was poor and lost distension a couple of times and unfortunately nicked the bladder twice.The surgeon aborted the procedure and change to a standard transurethral resection of the prostate (turp) procedure to complete the case.An additional procedure was needed to repair the patient's bladder.Later, the initial reporter clarified that the suction to the canisters was working fine.The blades would not hold or bite the tissue.The operation time was prolonged by 90 minutes due to the surgical staff trying to resolve the issue.

• Brand Name: POWER CONTROL
• Common Device Name: MOTOR CONTROL UNIT 2303
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen,, germany 75438 ; GM 75438
• MDR Report Key: 18743618
• Report Number: 1418479-2024-00001
• Device Sequence Number: 12361299
• Product Code: GEY
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/20/2024
• Report Date (Section F): 02/20/2024

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
• Operator of Device: Other
• Device Model Number: 2303011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2024
• Device Age: 17 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART ID: 2030108 / (B)(6)FOOTSWITCH PEDAL; PART ID: 2208011 / (B)(6)SUCTION PUMP; PART ID: 8170.6554 / 1499332 CONNECTION TUBE PUMP; PART ID: 8564.021 / (B)(6)MOTOR HANDPIECE; PART ID: 8564.021 / (B)(6)MOTOR HANDPIECE; PART ID: 8564.851 / LOT# 160425 CONNECTION CABLE; PART ID: 8564.851 / LOT# 230468 CONNECTION CABLE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 02/20/2024