MAUDE Adverse Event Report: RICHARD WOLF GMBH MOTOR CONTROL UNIT

Model Number	2303.011
Medical Device Problem Codes	Pumping Problem (3016); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic considers this case open.The user facility and manufacturer will be contacted again in an effort to collect missing information.
Event or Problem Description
On (b)(6) 2018, the user facility reported the following to richard wolf medical instruments (rwmic): "the piranha is presenting difficulties during interventions.The equipment is shutting down several times during the procedures and the morcellator also has speed changes".Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? unknown.Was there any injury or illness to patient or other personnel due to issue? unknown.Did the issue cause a delay in the procedure being performed that put the patient at risk? unknown.Was there a similar back-up device available for use? unknown.Was the scheduled procedure completed? unknown.How was the patient anesthetized? unknown.On march 13, 2019, rwmic received additional information from the sales representative: was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to the patient or other personnel due to this issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a back-up device available for use? no.Was the scheduled procedure completed? yes, with great difficulty.Was the patient anesthetized? yes.
Event or Problem Description
The user facility returned the device to richard wolf medical instruments corporation (rwmic) on march 12, 2019 and the device evaluation was completed on july 09, 2019.The device was visually, functionally, and electrically evaluated.The reported condition could not be verified, the inspection of the motor control unit did not reveal any function problems.The device met specifications and there was no manufacturing defect identified.
Additional Manufacturer Narrative
The following fields contain new/changed information: b5, f7, f8, f9, f11, f13, g4 g7, h2, h3, h4 h6, h10.Device labeling was reviewed for patient and device codes, see below: -patient code: not applicable, no patient problem was reported.-device code: ifu was reviewed, see below: important! run through the checks before and after each use.Do not use the products if they are damaged or incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Important! morcellation must only be carried out with power stick m4! during morcellation power stick m3 can become clogged by tissue parts in the handle.Important! work only with the recommended speed settings and under continuous irrigation.If the speed is set too high or if there is no irrigation the inner blade can seize or wear out quickly.If the speed is too low it can clog up.If the suction channel is clogged by tissue parts, morcellation is adversely affected.Clean a clogged suction channel with a suitable cleaning brush attempts were made to collect additional/missing information from the user facility, but no additional information could be provided.Rwmic considers this case closed.Should additional information become available a follow up report will be submitted.

• 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: 8511437
• Report Number: 1418479-2019-00014
• Device Sequence Number: 1780644
• Product Code: HRX
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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,Followup
• Report Date (Section B): 03/13/2019
• Report Date (Section F): 08/09/2019

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: No Information
• Device Model Number: 2303.011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/13/2019
• Device Age: 3 YR
• Date Report to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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: Other
• Date Report Sent to FDA: 08/09/2019