MAUDE Adverse Event Report: RICHARD WOLF GMBH POWER STICK M4; MOTOR HANDPIECE MAX. 6000RPM

Model Number 8564021

Device Problem Difficult to Open or Close (2921)

Patient Problem Embolism/Embolus (4438)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to richard wolf by the sales rep that "hand pieces would not hold tissue." responses to questions from the device complaint form - initial report will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.Email correspondence with customer service (1/19/2022): how long was each delay? for part 8564.021 s/n (b)(4): 5 minutes.For part 8564.021 s/n (b)(4): 45 minutes.What actions were being done during each delay? new tray was grabbed during first delay.Patient had to be prepped for an open procedure conversion after second delay.What were the risks to the patients? patient had to be opened up to remove tissue.Did the patients require any additional treatment during the delay or will require another procedure as the result of the delay? patient was brought back later for a clot evacuation.What was each of the patient's outcome? patient ended up ok.Email correspondence with customer service (1/21/2022) were both hand pieces used during the same procedure or were they used during different ones? both were used in the same procedure which devices were used with the handles: the piranha morcellation system and morcescope did they check the whole system to find the problem or just changed the hand pieces when the problem arose? two morcellators were used and hand pieces were changed.Is it sure that the problem occurred by the hand pieces and not by the pump, tubes, or any other accessories? yes, all items were checked after.Pumps worked perfectly with other handpieces.All tubing and disposables were changed during the procedure.Were the other devices used checked after the procedure for any problems? yes - if they were checked, did they work properly? yes - if not, we may suggest the user to send these devices to rw for investigation, too.Date of the event is unknown, the user facility will be contacted for additional information.

Manufacturer Narrative

Follow-up report #1 is to provide fda with the results of the device investigation/evaluation and any missing, new, and/or changed information.New information: results of the device investigation/evaluation from the manufacturer (section h10): the manufacturer reports that the device was tested using visual and functional means.The reported condition, hand piece would not hold tissue, was confirmed.The investigation found "that the plug pin is heavily corroded, the o-ring at the valve worn out, the magnet screw is leaking.However, according to the specifications, the motor function is ok." probable root cause: user error, normal wear and tear.Product disposition: to be determined.Device labeling was reviewed for patient code and device codes, see below: - patient code: not applicable, no patient problem was reported.From the ifu ga-202, ga-a238.7.2.1 maintenance intervals important! to avoid any incidents or damage caused by aging and wear it is necessary to service the product and the accessories at adequate intervals.Depending on the frequency of use, but at least once a year, have an expert check the functional and operational safety of the equipment.From the ifu ga-a238.The user is advised in the ifu ga-a238-us / en / 2020-12 v6.0 / pk20-0352 in section 4.1 visual check to check all parts for any damage.The o-ring is mentioned explicitly to change if it is damaged.The ifu: " the o-ring (16.6) in the tool holder (clamping head) in power stick m4 must be in place and undamaged.- if the o-ring (16.6) is damaged, replace by cutting it open using a scalpel and installing a new one." 7.2 maintenance.Important! in your inquiries or correspondence please always indicate the model and serial number on the identification plate.Further documentation is available from the manufacturer on request.Richard wolf service: www.Richard-wolf.Com/en-us/service-and-service-packages to avoid malfunctions, a regular function test and a check of the controls and the connection for damage must be carried out before every new start-up.In accordance with the instructions for use (manual), the user is responsible for the functionality of the footswitch.Device history was reviewed, no record of device being returned to importer or manufacturer for maintenance.

Event Description

The purpose of this submission is to report the results of the device investigation.

Manufacturer Narrative

Follow-up report #2 is to provide fda with new information about this mdr.Corrected data: d9 - device available for evaluation? (device returned to manufacturer: 01/14/2022, instead of 01/17/2022).The user facility was contacted several times in an effort to collect patient information and user information.As of 29-sept-2022, rwmic has not received a response.Dates of user facility contact: 1st contact: 1/28/2022 via email: no response; 2nd contact: 8/12/2022 via email: no response; 3rd contact: 9/28/2022 via email: no response.Richard wolf medical instruments corporation (rwmic) considers this mdr closed.Rwmic will submit a follow up report if new information becomes available.

Event Description

Rwmic complaint reference no.(b)(4).The purpose of this submission is to provide results of due diligence for patient information, as well as, to close this mdr.See h10.

Manufacturer Narrative

Follow-up report #3 is to provide fda with new information about this mdr.The following fields have new information: a1, a3, a5, a6, b4, b5, f7, f8, f11, f13, and h10.The user facility have provided the patient information via email dated, (b)(6) 2022.Information received: patient identifier- (b)(6).Age at the time of event or date of birth- information not available sex- m.Weight- information not available.Ethnicity- african american.Race- african american.Richard wolf medical instruments corporation (rwmic) considers this mdr closed.Rwmic will submit a follow up report if new information becomes available.

Event Description

Rwmic complaint reference no.(b)(4).The purpose of this submission is to provide patient information recently received from user facility.See h10.

• Brand Name: POWER STICK M4
• Type of Device: MOTOR HANDPIECE MAX. 6000RPM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 13384905
• MDR Text Key: 289427765
• Report Number: 1418479-2022-00004
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 04055207017982
• UDI-Public: 04055207017982
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8564021
• Device Catalogue Number: 8564.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2022
• Distributor Facility Aware Date: 01/05/2022
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MORCESCOPE.; PIRANHA MORCELLATION SYSTEM.; TUBING AND DISPOSABLES.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American