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

Model Number 2303011

Device Problem Decrease in Suction (1146)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

It was reported to rw by the user facility that: this is our technician's description of the issue: it won't build suction at times and sometimes when it does it won't hold suction.Other times it can go through a case with no issues.It's beyond being able to pin point from the surface level as some days it's fine and some days it's not and for this reason i feel it needs to be sent in as the doctor was very disappointed in the results of the surgery today.He has been patient as we try to do our best but he needs something done about it.Wolf only offers common trouble shooting over the phone, unplugging resetting etc.The wolf rep i spoke to (b)(6)advised it may be a pinch valve which is a common issue and they actually have multiple units lately get sent in for this reason.Additional details that were reported later: was the item being used on a patient at the time? yes the morcellator was being used on the patient during the error.Was there injury or illness to the patient because of the issue? no injury or illness was there injury or illness to any other personnel? no.Did it cause a delay in the procedure? yes we had to keep pausing as the machine kept losing suction.Did the delay put the patient at risk? anytime the patient is under for surgery time is of the essence.Was there a similar device available for back up use? no.Was the procedure completed? yes the procedure was completed.Please provide, in detail, what the issue was with your item: the morcellator unit will at times not build suction, in this particular case it built suction but during use would not maintain suction.This would cause the blade to stop moving and the unit would start to build suction from the halfway mark.All basic trouble shooting was done such as unplugging, resetting, checking tubing, etc but to no avail.

Event Description

The purpose of this report is to share the results of the device investigation.The device was visually and functionally evaluated.According to the investigation report "the motor control unit 2303.011 was tested according to the work instruction aaw03-098-0630.The customer's complaint could not be reproduced on the device, however according to the change form pk20-0110, a software update is required.The software was updated only after the investigation was closed." the device was returned to the customer with software upgrade.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: user facility was contacted three times in an effort to collect patient information and user information.9/24/2021 we received a response that no new information will be provided.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.The purpose of this submission is to notify fda that rwmic considers this mdr closed.The device investigation report was submitted on a prior submission and there has been no response from the user facility.Rwmic will submit a follow up report should new information become available.

Event Description

The purpose of this submission is to close this medical device report.

• Brand Name: POWER CONTROL
• Type of Device: MOTOR CONTROL UNIT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12304681
• MDR Text Key: 267297415
• Report Number: 1418479-2021-00038
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (y/n): N
• PMA/PMN Number: K041610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2303011
• Device Catalogue Number: 2303011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUCTION PUMP (1418479-2021-00039)2208011