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

Model Number 2303011

Device Problems Failure to Cut (2587); Poor Visibility (4072)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2024

Event Type  Injury  

Event 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
• Type of Device: MOTOR CONTROL UNIT 2303
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen,, germany 75438 ; GM 75438
• MDR Report Key: 18743618
• MDR Text Key: 335791294
• Report Number: 1418479-2024-00001
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 02/20/2024
• Distributor Facility Aware Date: 02/10/2024
• Device Age: 17 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White