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

Model Number	2303.011
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The present motor control unit with the serial number (b)(4) originates from batch 1320301 and was created on (b)(6) 2016 in a lot size of 6 pieces to the new goods warehouse and richard wolf usa at the 08.08.2016 delivered.The review of the throughput plan did not reveal any anomalies.The motor control unit is used in conjunction with a motor handle.(e.G.Power stick m4) to drive richard wolf rotary knives/ milling cutters for the removal of tissue during endoscopic procedures.One simultaneous extraction allows the continuous removal of the of worn tissue.The inspection of the motor control unit revealed that the customer complaint can be traced.The ek motor control unit board 64352047 is defective.The cause of this failure is due to a sporadic defect.The evaluation of the available information does not lead to a direct patient risk, as the product is not suitable for the functional impairment cannot be applied.In the rule, the user recognizes during the visual and functional check whether damage or function-relevant defects are present.The ga-a202 operating instructions contain sufficient information on the visible and function control, as well as application and handling.Among other things, the products must also be available with regard to missing parts as well as damages or functional impairments before and after each application can be controlled.In order to avoid dangers for users, patients and to keep third parties away.Hazards due to manufacturing and handling which can lead to functional impairments have been taken into account in the risk assessment.And assessed with an acceptable risk.These however, valuations represent the worst-case scenario and are not this is comparable to the complaint described above.This case is considered closed, however, in the event that additional information is obtained, a follow up report will be submitted to fda.
Event or Problem Description
On (b)(6) 2019, richard wolf medical instruments corporation (rwmic) received the following information: during morcelattion, unit stopped working.There was a triangle error code and the alarm went off.There was no patient injury and the case was not completed.

• Brand Name: POWER CONTROL
• Common Device Name: MOTOR CONTROL UNIT 2303
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10163697
• Report Number: 1418479-2019-00023
• Device Sequence Number: 11725634
• Product Code: HRX
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2019
• Report Date (Section F): 06/17/2020

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: 10/01/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 06/17/2020
• 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: Other
• Date Report Sent to FDA: 06/17/2020