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

Model Number 2303011

Device Problem Suction Failure (4039)

Patient Problem Laceration(s) (1946)

Event Date 12/10/2021

Event Type  Injury  

Event Description

It was reported to richard wolf: there was a lack of engagement between the piranha and the prostate tissue.While trying to capture the freed prostate tissue the bladder was caught instead.We tried a different handle, piranha machine, blade, and canister and experienced the same issue a second time.The case was completed but dr.Sloan had to remove the remaining tissue with a grasper and lengthy lasering.No repairs to the bladder were made.A third machine and two different handles were used on the next two cases with no problems.Transcript of voicemail left by sales manager: the person i'm with today dr.(b)(6) had an injury where there wasn't enough suction coming from the machine.So it wasn't engaging the prostate tissue and in attempting to get the prostate tissue into/to engage the morcellator there was some bladder tissue that was captured instead.So we switched the scopes, machines, handle, and canisters and used the piranha again.It happened again, same thing, there wasn't enough suction to engage the prostrate tissue and it gathered bladder tissue instead.So it cut that patient twice.I think i have discovered what the problem is: spd department banging piranha handle on counter to get pieces out, think that may have cracked morcellator to get all the pieces.Used two of their handles on two other patients and they went perfectly fine.This is the case that paula is connected to.While trying to capture the freed prostate tissue the bladder was caught instead.We tried a different handle, piranha machine, blade, and canister and experienced the same issue a second time (second cut to the bladder).The case was completed but dr.(b)(6) had to remove the remaining tissue with a grasper and lengthy lasering.No repairs to the bladder were made.A third machine and two different handles were used on the next two cases with no problems.Additional information provided by the user facility: will the piranha device be returned? no, i do not believe so.It was checked out, leak tested and monitored in our facility.Was there any injury or illness to any other personnel due to the reported issue? no, no other personnel reported an injury.Did the issue cause a delay in the procedure being performed? yes, we had to retrieve a new system/canister/hand piece therefore the physician did have to wait.What actions were being taken during the delay? the physician was able to work on lasering/cauterizing the prostate.Did the delay put the patient at risk? no, i don't believe the delay caused a risk to the patient.How long was the delay? 10 minutes approximately.Was another device needed? yes, we were able to use another wolf piranha system from our urology storage unit.Was there a similar back-up device available for use? yes, another piranha system was available.Was the scheduled procedure completed? yes, the scheduled procedure was completed.

Manufacturer Narrative

(b)(4) is submitting this report on behalf of richard wolf gmbh.(b)(4) is the importer of this device.(b)(4) considers this mdr open.(b)(4) will submit a follow up report after review of the product/device history has been completed and/or new information becomes available.

Manufacturer Narrative

Follow-up report #1 is to provide fda with results of the device history evaluation along with any missing information, new information, and changed information.Missing information: user facility was contacted 3 times in an effort to collect patient information and user information.As of 3/28/2022, rwmic received a response on some but not all (patient information) requested information.New information: the following fields have new information: h6, h10.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 closed.If rwmic receive new information a follow-up report will be submitted.The reported motor control unit 2303.011 with the serial number (b)(6) was produced on 02/20/2014 and it was delivered to rwmic on 03/26/2014.There are no further records about maintenance, repair or complaint regarding this motor control unit in the database of rwgmbh.The user is advised in the ifu ga-a202-us / en / 2020-10 v2.0 / pk20-0329 to service the motor control unit at least once a year to to avoid any incidents or damage caused by aging and wear.Since the reported motor control unit will not be returned for investigation, the root cause could not be determined.Rwgmbh has received 12 complaints regarding the motor control unit 2303.011 between 01/01/2019 and 01/04/2022.There was 1 complaint where rwgmbh has received, but not listed in the trend report from rwmic: 19-00083b / 700012123 - no malfunction was found.There were 4 complaints where no device problem was found: 20-00079a / 700014397, 21-00009 / 700015720, 21-00005b / 700015791, 21-00227a / 700016465.Since the motor control unit is used in a system, in many cases the malfunction could be caused by one of other devices in use.If these devices are not returned, the root cause of the case cannot be determine.The following 5 had sporadic failure: 19-00353a / 700013583 - sporadic failure of the e-board.20-00114a / 700014519 - no function of the e-board.20-00292a / 700015665 - sporadic failure of the ek controller.20-00292b / 700015679 - sporadic failure of the ek controller.21-00137 / 700016272 - no function of the potentiometer.There is 1 complaint where there was a 20-00239b / 700015244 - housing the device was bady bent, short circuuit due to mechanical overload.There is 1 complaint where the investigation is pending, device has not been received: 21-00399a / 700017323.There was 1 complaint where the involved devices differ from what was recorded in the complaint: 19-00118a / 700012306 - however, motor control unit 2303.001 were involved, see form 5006 / ra# 200329407 from 03/28/2019.Rw gmbh has no information about the following 4 complaints which are listed in trend report from rwmic: 21-00043b.21-00058b.21-00103b.21-00250.If these complaints were returned to rwgmbh as repair, they were not recorded in the complaint database.The following 11 complaints from the trend report were recorded in connection with different devices at rwgmbh, since no issues/malfunctions was found with the motor control unit: 19-00207a: 19-00207b / 700012813, 19-00430a: 19-00430b / 700013929, 20-00231b: 20-00239b / 700015244, 20-00264d: 20-00264b / 700015298, 21-00024b: 21-00024a / 700015908, 21-00025a: 21-00025b / 700016464, 21-00076b: 21-00076a / 700016500, 21-00077b: 21-00077a / 700016498, 21-00261a: 21-00261b / 700016585, 21-00412b: 21-00412a / 700017423, 21-00413b: 21-00413a / 700017424.

Event Description

Please see manufacturers narrative for results of the product history evaluation.

• Brand Name: POWER CONTROL
• Type of Device: MOTOR CONTROL UNIT 2303
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 13172323
• MDR Text Key: 288611771
• Report Number: 1418479-2021-00062
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2303011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PIRANHA SUCTION PUMP2208011
• Patient Outcome(s): Other; Other