MAUDE Adverse Event Report: RICHARD WOLF GMBH MOTOR CONTROL UNIT

Model Number	2303.011
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional attempts will be made to collect device information from the user facility and manufacturer.Rwmic considers this matter open.Follow-up reports will be submitted as required.
Event or Problem Description
On (b)(6) 2019, richard wolf medical instruments corporation (rwmic) received report regarding the two components of the piranha system: motor control unit part # 2303.011 - to be reported in mdr 1418479-2019-00031, suction pump part # 2208011 - to be reported in mdr 1418479-2019-00032.It was reported that the pump for the piranha is defective.Photos were provided and showed that the pump presented with "vacuum sensor defective" and "device defective" error codes.The following additional information was provided on (b)(6) 2019 by the initial reporter: the malfunction occurred during the middle of a procedure.The machine was turned off and back on in an attempt to resolve the issue.Additionally, the tubing, filters, prostate collection canister, as well as the lids on the fluid canisters and fluid canisters, were changed.There were cracks on the fluid collecting canisters noticed, the canisters were submerged in water later to confirm that there were no cracks present.As a result of the malfunction the surgeon had to convert the procedure to a transurethral resection of the prostate (turp) after they had already enucleated the prostate.The prostate tissue floating in the bladder had to be "turp'ed" resulting in an additional hour that the patient was under anesthesia.

• Brand Name: MOTOR CONTROL UNIT
• Common Device Name: MOTOR CONTROL UNIT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8833476
• Report Number: 1418479-2019-00031
• Device Sequence Number: 2586657
• Product Code: HRX
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K030082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019
• Report Date (Section F): 07/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: 2303.011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 07/26/2019